U.S. patent number 9,724,266 [Application Number 13/554,986] was granted by the patent office on 2017-08-08 for enhanced guided active compression decompression cardiopulmonary resuscitation systems and methods.
This patent grant is currently assigned to ZOLL MEDICAL CORPORATION. The grantee listed for this patent is Keith Lurie, Anja Metzger, Gregg Voss, Demetris Yannopoulos. Invention is credited to Keith Lurie, Anja Metzger, Gregg Voss, Demetris Yannopoulos.
United States Patent |
9,724,266 |
Voss , et al. |
August 8, 2017 |
**Please see images for:
( Certificate of Correction ) ** |
Enhanced guided active compression decompression cardiopulmonary
resuscitation systems and methods
Abstract
Systems and methods for applying enhanced guided active
compression decompression cardiopulmonary resuscitation are
provided. Exemplary systems include a load cell, a handle, an
adhesive pad. The handle and the adhesive pad are configured for
magnetic coupling.
Inventors: |
Voss; Gregg (Lakeville, MN),
Metzger; Anja (Stillwater, MN), Lurie; Keith
(Minneapolis, MN), Yannopoulos; Demetris (Saint Paul,
MN) |
Applicant: |
Name |
City |
State |
Country |
Type |
Voss; Gregg
Metzger; Anja
Lurie; Keith
Yannopoulos; Demetris |
Lakeville
Stillwater
Minneapolis
Saint Paul |
MN
MN
MN
MN |
US
US
US
US |
|
|
Assignee: |
ZOLL MEDICAL CORPORATION
(Chelmsford, MA)
|
Family
ID: |
47362502 |
Appl.
No.: |
13/554,986 |
Filed: |
July 20, 2012 |
Prior Publication Data
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Document
Identifier |
Publication Date |
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US 20120330200 A1 |
Dec 27, 2012 |
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Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
Issue Date |
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13026459 |
Feb 14, 2011 |
8702633 |
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13175670 |
Jul 1, 2011 |
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13554458 |
Jul 20, 2012 |
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61304148 |
Feb 12, 2010 |
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61361208 |
Jul 2, 2010 |
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61485944 |
May 13, 2011 |
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61509944 |
Jul 20, 2011 |
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61577565 |
Dec 19, 2011 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61H
31/004 (20130101); A61H 31/005 (20130101); A61H
2201/5061 (20130101); A61H 2201/5084 (20130101); A61H
2230/42 (20130101); A61H 2201/5043 (20130101); A61H
31/006 (20130101); A61H 2230/50 (20130101); A61H
2230/207 (20130101); A61H 2201/5064 (20130101) |
Current International
Class: |
A61H
31/00 (20060101) |
References Cited
[Referenced By]
U.S. Patent Documents
Foreign Patent Documents
|
|
|
|
|
|
|
1487792 |
|
Oct 1992 |
|
AU |
|
60539 |
|
Nov 1994 |
|
AU |
|
68792 |
|
May 1995 |
|
AU |
|
668771 |
|
Aug 1963 |
|
CA |
|
2077608 |
|
Mar 1993 |
|
CA |
|
2214887 |
|
Jul 2008 |
|
CA |
|
1183731 |
|
Jun 1998 |
|
CN |
|
2453490 |
|
May 1975 |
|
DE |
|
4308493 |
|
Sep 1994 |
|
DE |
|
0029352 |
|
May 1981 |
|
EP |
|
0139363 |
|
May 1985 |
|
EP |
|
0245142 |
|
Nov 1987 |
|
EP |
|
0367285 |
|
May 1990 |
|
EP |
|
0411714 |
|
Feb 1991 |
|
EP |
|
0509773 |
|
Oct 1992 |
|
EP |
|
0560440 |
|
Sep 1993 |
|
EP |
|
0623033 |
|
Nov 1994 |
|
EP |
|
1344862 |
|
Jan 1974 |
|
GB |
|
1465127 |
|
Feb 1977 |
|
GB |
|
2117250 |
|
Oct 1983 |
|
GB |
|
2139099 |
|
Nov 1984 |
|
GB |
|
2005000675 |
|
Jan 2005 |
|
JP |
|
2006524543 |
|
Nov 2006 |
|
JP |
|
2007504859 |
|
Mar 2007 |
|
JP |
|
9005518 |
|
May 1990 |
|
WO |
|
9302439 |
|
Feb 1993 |
|
WO |
|
9321982 |
|
Nov 1993 |
|
WO |
|
9426229 |
|
Nov 1994 |
|
WO |
|
95/13108 |
|
May 1995 |
|
WO |
|
9528193 |
|
Oct 1995 |
|
WO |
|
96/28215 |
|
Sep 1996 |
|
WO |
|
9820938 |
|
May 1998 |
|
WO |
|
9947197 |
|
Sep 1999 |
|
WO |
|
9963926 |
|
Dec 1999 |
|
WO |
|
0020061 |
|
Apr 2000 |
|
WO |
|
0102049 |
|
Jan 2001 |
|
WO |
|
0170092 |
|
Sep 2001 |
|
WO |
|
0170332 |
|
Sep 2001 |
|
WO |
|
02092169 |
|
Nov 2002 |
|
WO |
|
2004096109 |
|
Nov 2004 |
|
WO |
|
2006088373 |
|
Aug 2006 |
|
WO |
|
2008147229 |
|
Dec 2008 |
|
WO |
|
2010044034 |
|
Apr 2010 |
|
WO |
|
2013064888 |
|
May 2013 |
|
WO |
|
2013096495 |
|
Jun 2013 |
|
WO |
|
2014026193 |
|
Feb 2014 |
|
WO |
|
Other References
US 5,584,866, 12/1996, Kroll et al. (withdrawn) cited by applicant
.
Zhao, et al. "Inhibitation of Myocardial Injury By Ischemic
Postconditioning During RePerfusion Comparision With Ischemic
Preconditioning", Am J Physiol Heart Circ 285: H579-H588 (2003).
cited by examiner .
Lurie, Keith G. et al., "Regulated to Death: The Matter of Informed
Consent for Human Experimentation in Emergency Resuscitation
Research," Cardiac Arrhythmia Center at the University of
Minnesota, PACE 18:1443-1447 (Jul. 1995). cited by applicant .
International Search Report and Written Opinion of
PCT/US2011/024770 mailed on Apr. 6, 2011, 6 pages. cited by
applicant .
Yannopoulos, D., et al., "Intrathoracic Pressure Regulation
Improves 24-Hour Survival in a Porcine Model of Hypovolemic Shock."
Anesthesia & Analgesia, ITPR and Survival in Hypovolemic Shock,
vol. 104, No. 1, Jan. 2007, pp. 157-162. cited by applicant .
Yannopoulos, D., et al., "Intrathoracic pressure regulation
improves vital organ perfusion pressures in normovolemic and
hypovolemic pigs," Resuscitation, 2006, 70, pp. 445-453. cited by
applicant .
Aufderheide, T., et al., "Standard cardiopulmonary resuscitation
versus active compression-decompression cardiopulmonary
resuscitation with augmentation of negative intrathoracic pressure
for out-of-hospital cardiac arrest: A randomized trial," 2011,
Lancet, vol. 377, pp. 301-311. cited by applicant .
Segal, N., et al., "Ischemic Postconditioning at the Initiation of
Cardiopulmonary Resuscitation Facilitates Cardiac and Cerebral
Recovery After Prolonged Untreated Ventricular Fibrillation,"
Resuscitation, Apr. 18, 2012, 7 pages. cited by applicant .
Schultz, J., et al., "Sodium nitroprusside enhanced cardiopulmonary
resuscitation (SNPeCPR) improves vital organ perfusion pressures
and carotid blood flow in a porcine model of cardiac arrest,"
Resuscitation, 2012, vol. 83, pp. 374-377. cited by applicant .
Yannopoulos, D., et al., "Controlled pauses at the initiation of
sodium nitroprusside-enhanced cardiopulmonary resuscitation
facilitate neurological and cardiac recovery after 15 minutes of
untreated ventricular fibrillation," Critical Care Medicine, 2012,
vol. 40, No. 5, 8 pages. cited by applicant .
Yannopoulos, D., et al., "Sodium nitroprusside enhanced
cardioplumonary resuscitation improves survival with good
neurological function in a porcine model of prolonged cardiac
arrest," Critical Care Medicine, 2011, vol. 39, No. 6, 6 pages.
cited by applicant .
Advanced Circulatory Systems, Inc. (Jan. 2014), Emerging Data: The
Resuscitation Outcomes Consortium (ROC) PRIMED Study on the
Efficacy of the ITD (#49-0864-000,06) [Brochure], Roseville,
MN:Advanced Circulatory Systems, Inc. 2 pages. cited by applicant
.
Advanced Circulatory Systems, Inc. (Jan. 2013), Emerging Data: The
Resuscitation Outcomes Consortium (ROC) PRIMED Study on the
Efficacy of the ITD (#49-0864-000,05) [Brochure], Roseville,
MN:Advanced Circulatory Systems, Inc. 2 pages. cited by applicant
.
Advanced Circulatory Systems, Inc. (Mar. 2012), Benefits of the
ResQPOD Based Upon the ROC PRIMED Study (#49-0864-000,04)
[Brochure], Roseville, MN:Advanced Circulatory Systems, Inc. 2
pages. cited by applicant .
Advanced Circulatory Systems, Inc. (Jan. 2012), Benefits of the
ResQPOD Based Upon the ROC PRIMED Study (#49-0864-000,03)
[Brochure], Roseville, MN:Advanced Circulatory Systems, Inc. 2
pages. cited by applicant .
Advanced Circulatory Systems, Inc. (Aug. 2011),Early Intervention
is Life-Saving in Cardiac Arrest (#49-0864-000,01) [Brochure],
Roseville, MN:Advanced Circulatory Systems, Inc. 2 pages. cited by
applicant .
Advanced Circulatory Systems, Inc. (Aug. 2011),Early Intervention
is Life-Saving in Cardiac Arrest (#49-0864-000,02) [Brochure],
Roseville, MN:Advanced Circulatory Systems, Inc. 2 pages. cited by
applicant .
Advanced Circulatory Systems, Inc. (2013), ResQPOD More than a
Heartbeat (#49-0336-000,08) [Brochure], Roseville, MN:Advanced
Circulatory Systems, Inc. 2 pages. cited by applicant .
Advanced Circulatory Systems, Inc. (2011), ResQPOD
ITD:Strengthening the Chain of Survival (#49-0336000,06)
[Brochure], Roseville, MN:Advanced Circulatory Systems, Inc. 2
pages. cited by applicant .
Advanced Circulatory Systems, Inc. (2010), ResQPOD Impedance
Threshold Device:Strengthening the Chain of Survival
(#49-0336000,05) [Brochure], Roseville, MN:Advanced Circulatory
Systems, Inc. 2 pages. cited by applicant .
Advanced Circulatory Systems, Inc. (2010), ResQPOD Impedance
Threshold Device:Strengthening the Chain of Survival
(#49-0336000,04) [Brochure], Roseville, MN:Advanced Circulatory
Systems, Inc. 2 pages. cited by applicant .
Advanced Circulatory Systems, Inc. (2010), ResQPOD Impedance
Threshold Device 10.0:Strengthening the Chain of Survival
(#49-0336000,03) [Brochure], Roseville, MN:Advanced Circulatory
Systems, Inc. 2 pages. cited by applicant .
Advanced Circulatory Systems, Inc. (2006). ResQPOD.RTM. Circulatory
Enhancer: Strengthening the Chain of Survival (#49-0336-000, 02).
[Brochure]. Roseville.MN: Advanced Circulatory Systems, Inc., 2
pages. cited by applicant .
Advanced Circulatory Systems, Inc. (2006). ResQPOD.RTM. Circulatory
Enhancer: Strengthening the Chain of Survival (#49-0336-000, 01)
[Brochure]. Roseville, MN: Advanced Circulatory Systems, Inc.. 2
pages. cited by applicant .
Advanced Circulatory Systems. Inc. (2011). ResQPOD.RTM. Perfusion
on Demand: ResQPOD Impedance Threshold Device (#49-0324-001, 05)
[Brochure]. Roseville, MN: Advanced Circulatory Systems, Inc., 2
pages. cited by applicant .
Advanced Circulatory Systems, Inc. (2011). ResQPOD.RTM. Perfusion
on Demand: ResQPOD Impedance Threshold Device (#49-0324-001, 04)
[Brochure]. Roseville, MN: Advanced Circulatory Systems, Inc.. 2
pages. cited by applicant .
Advanced Circulatory Systems,lnc. (2010). ResQPOD.RTM. Perfusion on
Demand: ResQPOD Impedance Threshold Device (#49-0324-001, 03)
[Brochure]. Roseville, MN: Advanced Circulatory Systems, Inc., 2
pages. cited by applicant .
Advanced Circulatory Systems,lnc. (2009). ResQPOD.RTM. Perfusion on
Demand: ResQPOD Impedance Threshold Device (#49-0324-001, 02)
[Brochure]. Roseville, MN: Advanced Circulatory Systems, Inc., 2
pages. cited by applicant .
Advanced Circulatory Systems,Inc. (2005). Introducing ResQPOD.RTM.
(#49-0324-000, 01) [Brochure]. Roseville, MN: Advanced Circulatory
Systems, Inc., 2 pages. cited by applicant .
Ambu InternationalNS Directions for use of Ambu.RTM. CardioPump.TM.
.cndot.. Sep. 1992, 8 pages. cited by applicant .
Babbs, Charles F.MD. PhD., CPR Techniques that Combine Chest and
AbdominalCompression and Decompression: Hemodynamic Insights from a
Spreadsheet Model, Circulation,1999, pp. 2146-2152. cited by
applicant .
Christenson, J.M.. "Abdominal Compressions During CPR: Hemodynamic
Effects of Altering Timing and Force", The Journal of Emergency
Medicine, vol. 10, pp. 257-266, 1992. cited by applicant .
Cohen, Todd J. et a.l . "Active Compression-Decompression
Resuscitation: a Novel Method of Cardiopulmonary Resuscitation",
Department of Medicine and the Cardiovascular Research Institute,
UC San Francisco, American Heart Journal 124(5):1145-1150, 1992.
cited by applicant .
Cohen, Todd J. et al., "Active Compression-Decompression: A New
Method of Cardiopulmonary Resuscitation", JAMA 267(21): 2916-2923
(Jun. 3, 1992). cited by applicant .
Dupuis, Yvon G., Ventilators--Theory and Clinical Application, pp.
447-448, 481, 496; Jan. 1986, Mosby Company. cited by applicant
.
Geddes, L.A. et al., "Inspiration Produced by Bilateral
Electromagnetic, Cervical Phrenic Nerve Stimulation in Man," IEEE
Transactions on Biomedical Engineering 38(9): 1047-1048 (Oct.
1991). cited by applicant .
Geddes, L.A. et al., "Optimum Stimulus Frequency for Contracting
the Inspiratory Muscles with chest Surface Electrodes to Produce
Artificial respiration," Annals of Biomedical Engineering
18:103-108 (1990). cited by applicant .
Geddes, L.A. et al., "Electrically Produced Artificial
Ventilation," Medical Instrumentation, vol. 22(5); 263-271, 1988.
cited by applicant .
Geddes, L.A., "Electroventilation--A Missed Opportunity?",
Biomedical Instrumentation & Technology, Jul./Aug. 1998, pp.
401-414. cited by applicant .
Glenn, William W.L. et al.,"Diaphragm Pacing by Electrical
Stimulation of the Phrenic Nerve," Neurosurgery 17(6): 974-984
(1985). cited by applicant .
Glenn, William W.L., et al., "Twenty Years of Experience in Phrenic
Nerve Stimulation to Pace the Diaphragm," Pace 9: 780-784
(Nov./Dec. 1986, Part I). cited by applicant .
Guidelines for Cardiopulmonary Resuscitation and Emergency Cardiac
Care, JAMA, 1992:268;2172-2295. cited by applicant .
Kotze, P.L. et al., "Diaphragm Pacing in the Treatment of
Ventilatory Failure,"San. Deel68:223-224 (Aug. 17, 1995). cited by
applicant .
Laghi, Franco et al., "Comparison of Magnetic and Electrical
Phrenic Nerve Stimulation in assessment of Diaphragmantic
Contractility," American Physiological society, pp. 1731-1742
(1996). cited by applicant .
Lindner, Karl H. et al., "Effects of Active
Compression-Decompression Resuscitation on Myocardialand Cerebral
Blood Flow in Pigs," Department of Anesthesiology and CriticalCare
Medicine, University of Ulm, Germany, Circulation
88(3):1254-1263,(Oct. 7, 1993). cited by applicant .
Aufderheide,T.,et al.,"Hyperventilation-induced hypotension during
cardiopulmonary resuscitation," Circulation ; Apr. 27, 2004;
109(16):1960-5. cited by applicant .
Lurie, K., et. Al., Comparison of a 10-Breaths-Per-Minute Versus a
2-Breaths-Per-Minute Strategy During Cardiopulmonary Resuscitation
in a Porcine Model of Cardiac Arrest,: Respiratory Care, 2008, vol.
53, No. 7, pp. 862-870. cited by applicant .
Michigan Instruments, Inc.Thumper 1007CC Continuous Compression
Cardiopulmonary Resuscitation System, obtained online Jul. 15, 2006
at http://WwW.michiganinstruments.com/resus-thumper.htm, 2 pages.
cited by applicant .
Shapiro et al., "Neurosurgical Anesthesia and Intracranial
Hypertension" Chapter 54, Anesthesia; 3rd Edition; Ed. Ron Miller
1990. cited by applicant .
Yannopoulos, Demetris et al., "Intrathoracic Pressure Regulator
During Continuous-Chest-Compression Advanced Cardiac Resuscitation
Improves Vital Organ Perfusion Pressures in a Porcine Modelof
Cardiac Arrest", Circulation, 2005, pp. 803-811. cited by applicant
.
Zhao, et. Al., Inhibation of a Myocardial Injury by Ischemic
Postconditioning During RePerfusion:Comparison with Ischemic
Preconditioning, Am. J. Physiol Heart Circ 285: H579-H588 (2003).
cited by applicant .
Edelson et al. Effects of compression depth and pre-shock pauses
predict defibrillation failure during cardiac arrest. Resuscitation
2006, vol. 71, pp. 137-145. cited by applicant .
Sato et al. Adverse effects of interrupting precordial compression
during cardiopulmonary resuscitation. Crit. Care Med. 1997, vol.
25, No. 5, pp. 733-736. cited by applicant .
Steen et al. The critical importance of minimal delay between chest
compressions and subsequent defibrillation: a haemodynamic
explanation. Resuscitation 2003, vol. 58, pp. 249-258. cited by
applicant .
Yu et al. Adverse outcomes of interrupted precordial compression
during automated defibrillation. Circulation 2002, vol. 106, pp.
368-372. cited by applicant .
Zhao, et al., Inhibitation of Myocardial Injury By Ischemic
Postconditioning During RePerfusion: Comparision With Ischemic
Preconditioning, Am J Physiol Heart Circ 285: H579-H588 (2003).
cited by third party.
|
Primary Examiner: Thanh; Quang D
Attorney, Agent or Firm: The Webb Law Firm
Parent Case Text
CROSS-REFERENCES TO RELATED APPLICATIONS
This application is a continuation-in-part of U.S. patent
application Ser. No. 13/026,459, filed Feb. 14, 2011, which is a
nonprovisional of and claims the benefit of priority to U.S.
Provisional Patent Application No. 61/304,148, filed Feb. 12, 2010.
This application is also a continuation-in-part of U.S. patent
application Ser. No. 13/175,670, filed Jul. 1, 2011, which is a
nonprovisional of and claims the benefit of priority to U.S.
Provisional Patent Application Nos. 61/361,208, filed Jul. 2, 2010
and 61/485,944, filed May 13, 2011. This application is also a
continuation-in-part of U.S. patent application Ser. No.
13/554,458, filed Jul. 20, 2012, which claims the benefit of
priority to U.S. Provisional Application No. 61/509,994 filed Jul.
20, 2011. This application also claims the benefit of U.S.
Provisional Application Nos. 61/509,994, filed Jul. 20, 2011 and
61/577,565 filed Dec. 19, 2011. The entire disclosure of each of
the above referenced filings is incorporated herein by reference
for all purposes.
Claims
What is claimed is:
1. A system for applying guided active compression decompression
cardiopulmonary resuscitation to an individual by an operator,
comprising: a compression element that is pressed and lifted by the
operator; a flexible surface element operably coupled with the
compression element by a connection mechanism and configured to
contact the individual's chest, the flexible surface element
removably attachable to a chest area of the individual, the
flexible surface element configured to decouple from the
compression element when a decompression force exceeds a
predetermined limit; an operator interface that provides guidance
to the operator as to how to perform chest compressions; a
processor operably coupled with the operator interface; and a
memory that is configured to store instructions executable by the
processor to: provide a set of operator instructions to perform a
first conditioning protocol for increasing circulation in the
individual by compressing the chest in a repeated manner for a
certain number of chest compressions, a second conditioning
protocol for pausing or reducing circulation in the individual
following the first conditioning protocol by stopping chest
compressions for a certain time duration, and a third conditioning
protocol for increasing circulation in the individual following the
second protocol by again compressing the chest in a repeated manner
for a certain number of chest compressions.
2. The system according to claim 1, wherein each of the first and
third conditioning protocols comprise a series of periodic active
chest compressions and decompressions.
3. The system according to claim 1, wherein each of the first and
third conditioning protocol comprise a duration, and the first
conditioning protocol duration is different from the second
conditioning protocol duration.
4. The system according to claim 1, wherein each of the first and
third conditioning protocol comprise a duration, and the first
conditioning protocol duration is equal to the second conditioning
protocol duration.
5. The system according to claim 1, wherein the first conditioning
protocol comprises a duration of about 40 seconds, the duration of
the second conditioning protocol is about 20 seconds, and the third
conditioning protocol comprises a duration of about 40 seconds.
6. The system according to claim 1, wherein the operator interface
comprises a display subsystem that provides at least a portion of
the guided treatment instructions.
7. The system according to claim 1, wherein the operator interface
comprises an audio output device that provides at least a portion
of the guided treatment instructions.
8. The system according to claim 7, wherein the audio output device
comprises a loudspeaker.
9. The system according to claim 1, wherein the operator interface
comprises a display subsystem and an audio output device that
provide at least a portion of the guided treatment
instructions.
10. The system according to claim 1, further comprising a means for
delivering an electrical defibrillation treatment to the
individual.
11. The system according to claim 1, wherein the set of operator
instructions is based at least in part on a physiological parameter
of the patient, and wherein the physiological parameter of the
patient is selected from the group consisting of a ventilation
rate, a body temperature, a heart rate, a respiratory rate, a vital
sign, and an end tidal carbon dioxide measure.
12. The system according to claim 1, further comprising a pressure
regulator mechanism that modulates pressure within an airway of the
individual.
13. The system according to claim 1, wherein the memory is
configured to store instructions executable by the processor to
receive information indicating whether the operator is following
the set of operator instructions and to provide a signal indicating
whether the operator is following the set of operator
instructions.
14. The system according to claim 1, wherein the flexible surface
element coupled with the compression element and removably
attachable to the chest area of the individual is from 2 to 4 times
larger than a compressive area defined by a portion of the
compression element that couples to the flexible surface
element.
15. The system according to claim 1, wherein the flexible surface
element coupled with the compression element and removably
attachable to the chest area of the individual includes an adhesive
for attaching to the chest area of the individual.
16. The system according to claim 1, wherein the connection
mechanism comprises magnetic connection between the flexible
surface element and the compression element.
Description
BACKGROUND OF THE INVENTION
Embodiments of the present invention relate generally to systems
and methods for active compression decompression (ACD)
cardiopulmonary resuscitation (CPR), and in particular to guided
approaches which assist an operator in administering appropriate
technique in an effective manner.
Sudden cardiac arrest is a major cause of death worldwide and can
arise from a variety of circumstances, including heart disease and
trauma such as electrical shock and suffocation. To improve a
patient's chance of survival (and diminish the likelihood of brain
and heart damage resulting from oxygen deprivation), it is
important that measures be taken as soon as possible to at least
partially restore the patient's respiration and blood circulation.
Many years ago, techniques for external chest compression,
generally referred to as cardiopulmonary resuscitation (CPR), were
developed and have enjoyed great success in reducing mortality
resulting from sudden cardiac arrest. Certain aspects of such
techniques, however, have remained largely unchanged over recent
years.
External chest compression relies on actively applying pressure to
the patient's chest in order to increase intrathoracic pressure.
Such pressure increase will induce blood movement from the region
of the heart and lungs through the peripheral arteries, thus
partially restoring the patient's circulation. Phase 1 of
traditional CPR is referred to as the "active compression phase"
where the chest is compressed by the direct application of external
pressure. Phase 2, referred to as the "relaxation phase," occurs
when pressure is withdrawn and the natural elasticity of the
patient's chest wall causes expansion. While such expansion is
generally sufficient to refill the cardiac chambers with some
blood, it is insufficient to ventilate the patient, i.e., fill the
lungs with sufficient air to oxygenate the blood. Thus,
conventional CPR further requires periodic ventilation of the
patient, e.g., mouth-to-mouth ventilation, in order to provide the
air necessary for blood oxygenation.
Manual CPR procedures generally require performers to lean over the
patient and to apply pressure using the palms of their hands to the
patient's sternum as the patient lies supine on a flat surface. If
no one else is available, the performer must periodically shift
position to ventilate the patient through a mouth-to-mouth
procedure. Such manual procedures are thus very tiring to the
performer and furthermore have been found to result in only
marginal circulation.
Manual CPR procedures can also result in injury to the patient. For
example, pressure applied by the palm of the hand can fracture the
patient's sternum and/or ribs and cause other traumatic injury,
especially if the performer's hand position is inadvertently
shifted laterally to an improper location on the patient's chest.
The performance and safety of CPR procedures can be enhanced
through the use of various mechanical and automatic machines for
applying external chest compression and optionally ventilating the
patient by providing supplemental oxygen or air. The machines may
be as simple as a "cardiac press" which is a manually operated
lever which provides a mechanical advantage in performing chest
compression. More sophisticated machines can provide chest
compression and/or ventilation through a variety of other
mechanisms, including the use of pressurized chambers for
compressing the chest cavity. While such machines can be effective,
their bulk, weight, and cost limit their availability. In
particular, such machines are not widely available outside of
medical facilities and their size is a deterrent to providing such
equipment in emergency vehicles.
CPR is often administered in conjunction with other procedures
which, taken together, are referred to as advanced cardiac life
support (ACLS). Most commonly, CPR is administered while the
patient undergoes both electrocardiographic monitoring (ECM) and
electrical defibrillation. Although currently available CPR devices
can provide real benefits to patients in need thereof, in some
cases operator error or misuse may lead to ineffective treatment or
patient injury. Hence, further advances would be desirable. For
example, it would be desirable to provide improved systems and
methods for guiding a system operator who may be involved with
administering a treatment to a patient. Moreover, it would be
desirable to provide systems and methods that help to ensure
treatment is administered within desired or appropriate parameters.
Embodiments of the present invention provide solutions that address
the problems described above, and hence provide answers to at least
some of these outstanding needs.
BRIEF SUMMARY OF THE INVENTION
Embodiments of the present invention provide improved systems and
methods for performing external chest compression, optionally in
conjunction with CPR procedures. Such methods and systems provided
enhanced ventilation and blood circulation in the patient
undergoing treatment, preferably reducing or eliminating the need
to separately ventilate the patient. Desirably, the methods and
systems can be simple and easily stored so that they can be
maintained in emergency vehicles, non-medical facilities, and even
the home. The systems can be suitable for performing enhanced
manual CPR, in particular by converting, Phase 2 chest expansion
from a passive event to an active process to improve venous blood
return from the heart and enhance airflow into the lungs
(facilitated ventilation). Systems can provide guidance to
operators or technicians, such as digital outputs showing the
amount of force to be applied to a patient during a chest
compression or decompression. Further, systems may include handle
configurations which ensure appropriate forces are applied to the
patient.
Chest compression or decompression systems according to embodiments
of the present invention also provide a device contact area or
adhesive pad that is 2 to 4 times larger than the compressive area.
Such configurations can allow an operator to physically lift or
decompress a large surface area of the patient's chest. Relatedly,
such large surface contact areas can make it easier for an operator
or user to generate a full or greater decompression, thus resulting
in more blood flow back to the heart. What is more, embodiments of
the present invention provide compression surface areas which are
sufficiently large to confer enhanced coronary perfusion pressure
or increased blood flow from the heart to other organs or tissue
during compression.
Systems and methods disclosed herein can be used for actively
compressing and expanding an area of the human body, such as the
thoracic cavity or chest, the abdomen, the back, and the like.
Embodiments are useful for treating a variety of ailments wherein
such compression and expansion may be beneficial; for example,
heart failure, cardiac arrest, low blood pressure, poor blood
circulation, shock and other maladies affecting internal organs
such as the heart, stomach, intestines, liver, spleen, pancreas,
and the like. In some cases, embodiments may be particularly useful
for lowering or otherwise altering intrathoracic pressure (ITP) and
for ventilating patients who are not breathing. An exemplary
embodiment provides devices and methods for actively compressing
and decompressing the thoracic cavity in the performance of
cardiopulmonary resuscitation (CPR) and advanced cardiac life
support (ACLS) procedures.
In one aspect, embodiments of the present invention encompass
systems and methods for applying guided active compression
decompression cardiopulmonary resuscitation to an individual by an
operator. Exemplary systems include a compression element that is
pressed and lifted by the operator, a flexible surface element
coupled with the compression element and removably attachable to a
chest area of the individual, an operator interface that provides
guidance to the operator as to how to perform chest compressions,
and a processor operably coupled with the operator interface.
Systems may also include a memory that is configured to store
instructions executable by the processor to provide a set of
operator instructions to perform a first conditioning protocol for
increasing circulation in the individual by compressing the chest
in a repeated manner for a certain number of chest compressions or
for a first time duration, a second conditioning protocol for
pausing or reducing circulation in the individual following the
first conditioning protocol by stopping chest compressions for a
certain time duration, and a third conditioning protocol for
increasing circulation in the individual following the second
protocol by again compressing the chest in a repeated manner for a
certain number of chest compressions or for a third time duration.
In some instances, each of the first and third conditioning
protocols include a series of periodic active chest compressions
and decompressions. In some instances, each of the first and third
conditioning protocol include a duration, and the first
conditioning protocol duration is different from the third
conditioning protocol duration. In some cases, each of the first
and third conditioning protocol include a duration, and the first
conditioning protocol duration is equal to the third conditioning
protocol duration. In some instances, the first conditioning
protocol includes a duration of about 40 seconds, the duration of
the second conditioning protocol is about 20 seconds, and the third
conditioning protocol includes a duration of about 20 seconds or
about 40 seconds. In some instances, the operator interface
includes a display subsystem that provides at least a portion of
the guided treatment instructions. In some instances, the operator
interface includes an audio output device that provides at least a
portion of the guided treatment instructions. In some instances,
the audio output device includes a loudspeaker. In some instances,
the operator interface includes a tactile output device that
provides at least a portion of the guided treatment instructions.
In some instances, the tactile output device includes a vibration
mechanism. In some instances, the operator interface includes a
display subsystem and an audio output device that provide at least
a portion of the guided treatment instructions. In some instances,
systems may also include a means for delivering an electrical
defibrillation or shock treatment to the individual. In some
instances, the set of operator instructions is based at least in
part on a physiological parameter of the patient. In some
instances, the physiological parameter of the patient is a
ventilation rate, a body temperature, a heart rate, a respiratory
rate, a vital sign, an end tidal carbon dioxide measure, or any
combination thereof. In some cases, systems may also include a
pressure regulator mechanism that modulates pressure within an
airway of the individual. In some instances, the memory is
configured to store instructions executable by the processor to
receive information indicating whether the operator is following
the set of operator instructions and to provide a signal indicating
whether the operator is following the set of operator instructions.
In some instances, the memory is configured to store instructions
executable by the processor to receive information indicating
whether the individual has previously received a CPR treatment.
In another aspect, embodiments of the present invention encompass
systems and methods for providing guidance to an operator for
administering a chest compression treatment to an individual.
Exemplary systems may include a module that stores or receives
treatment information, and an operator interface that provides a
set of instructions to the operator based on the treatment
information. The set of instructions may include a first
conditioning protocol for increasing circulation in the individual,
the first conditioning protocol including compressing the chest in
a repeated manner for a certain number of chest compressions or for
a first time duration, a second conditioning protocol for pausing
or reducing circulation in the individual following the first
conditioning protocol, the second conditioning protocol including
ceasing chest compressions, and a third conditioning protocol for
increasing circulation in the individual following the second
protocol, the third protocol including again compressing the chest
in a repeated manner. In some instances, each of the first and
third conditioning protocols include a series of periodic active
chest compressions and decompressions. In some instances, each of
the first and third conditioning protocols include a duration, and
the first conditioning protocol duration is different from the
third conditioning protocol duration. In some instances, each of
the first and third conditioning protocol comprise a duration, and
the first conditioning protocol duration is equal to the third
conditioning protocol duration. In some instances, each of the
first and third conditioning protocol comprise a duration, and the
first conditioning protocol duration is greater than the third
conditioning protocol duration.
In another aspect, embodiments of the present invention encompass
systems and methods for administering a chest compression treatment
to an individual. Exemplary methods include providing audio and/or
visual and/or tactile instructions for performing repeated chest
compressions on the individual. Some exemplary methods may include
performing a first conditioning protocol for increasing circulation
in the individual based on the instructions, where the first
conditioning protocol includes compressing the chest in a repeated
manner for a certain number of chest compressions or for a certain
time duration, performing a second conditioning protocol for
pausing or reducing circulation in the individual following the
first conditioning protocol based on the instructions, where the
second conditioning protocol includes ceasing chest compressions,
and performing a third conditioning protocol for increasing
circulation in the individual following the second protocol based
on the instructions, where the third protocol includes again
compressing the chest in a repeated manner. In some instances, the
first conditioning protocol includes a series of periodic active
chest compressions and decompressions. In some instances, the third
conditioning protocol includes a series of periodic active chest
compressions and decompressions. In some instances, each of the
first and third conditioning protocols includes a series of
periodic active chest compressions and decompressions. In some
instances, methods further include delivering an electrical
defibrillation treatment to the individual. In some instances,
methods further include modulating a pressure within an airway of
the individual.
In yet another aspect, embodiments of the present invention
encompass systems for applying guided active compression
decompression cardiopulmonary resuscitation to an individual by an
operator. Exemplary systems may include a compression element that
is pressed and lifted by the operator, a flexible surface element
coupled with the compression element and removably attachable to a
chest area of the individual, an operator interface that provides
guidance to the operator as to how to perform chest compressions,
and a processor operably coupled with the operator interface.
Systems may also include a memory that is configured to store
instructions executable by the processor to provide a set of
operator instructions to perform a first conditioning protocol for
increasing circulation in the individual by compressing the chest
in a repeated manner for a first time duration, a second
conditioning protocol for pausing or reducing circulation in the
individual following the first conditioning protocol by stopping
chest compressions for a second time duration, and a third
conditioning protocol for increasing circulation in the individual
following the second protocol by again compressing the chest in a
repeated manner for a third time duration. In some instances, the
first time duration is about 40 seconds. In some instances, the
second time duration is about 20 seconds. In some instances, the
third time duration is about 20 seconds. In some instances, the set
of operator instructions further includes instructions to perform a
fourth conditioning protocol following the third conditioning
protocol, the fourth conditioning protocol including stopping chest
compressions for a fourth time duration. In some instances, the
fourth time duration is about 20 seconds. In some instances, the
set of operator instructions further includes instructions to
perform a fifth conditioning protocol following the fourth
conditioning protocol, the fifth conditioning protocol including
compressing the chest in a repeated manner for a fifth time
duration. In some instances, the fifth time duration is about 20
seconds. In some instances, the set of operator instructions
further includes instructions to perform a sixth conditioning
protocol following the fifth conditioning protocol, the sixth
conditioning protocol including stopping chest compressions for a
sixth time duration. In some instances, the sixth time duration is
about 20 seconds. In some instances, the set of operator
instructions further includes instructions to perform a seventh
conditioning protocol following the sixth conditioning protocol,
the seventh conditioning protocol including compressing the chest
in a repeated manner for a seventh time duration. In some
instances, the seventh time duration is within a range from about 0
seconds to about 60 seconds. In some instances, the set of operator
instructions further includes instructions to administer a
vasopressor agent to the individual. In some instances, the set of
operator instructions further includes instructions to administer a
vasodilator agent to the individual. In some instances, the set of
operator instructions further includes instructions to administer
an electrical shock to the individual. In some instances, the set
of operator instructions further includes instructions to assess
one or more physiological parameters of the individual. In some
instances, the set of operator instructions further includes
instructions to assess one or more physiological parameters of the
individual and instructions to administer an electrical shock based
on the assessed physiological parameter or parameters. In some
instances, systems include an input mechanism or button for
receiving an indication from the operator as to whether the
individual has previously received CPR. In some instances, the set
of operator instructions further include instructions to not
administer a stutter CPR therapy.
In one aspect, embodiments of the present invention encompass
systems and methods for ACD CPR. An exemplary system for applying
guided active compression decompression cardiopulmonary
resuscitation to an individual in need thereof can include, for
example, a handle, a load cell in operative association with the
handle, and an adhesive pad. The handle and the adhesive pad can be
configured for releasable coupling. In some cases, the handle and
the adhesive pad are configured for releasable magnetic coupling.
In some cases, a handle of an ACD CPR system can be coupled with a
drive element of an automated reciprocating system. In some cases,
an ACD CPR system may include or be used in conjunction with an
intrathoracic pressure regulator (ITPR) system that modulates
pressure within an airway of the individual.
In another aspect, embodiments of the present invention provide
systems and devices for actively compressing and expanding an area
of the body. A device can include a compression element that is
configured to be pressed and lifted, and a flexible surface element
operably coupled with the compression element and configured to be
removably attached to a body part over a contact area. In some
cases, the compression element is adapted to apply a compressive
force to the body part through the surface element over a
compressive area when the compression element is pressed. The
contact area can be sized to be at least twice as large as the
compressive area. In some cases, the contact area can be sized to
be in the range of two to three times as large as the compressive
area. Optionally, the surface element can be a generally planar
flexible contact pad the lower surface of which defines the contact
area. In some instances, the lower surface of the contact pad
includes an adhesive material. In some cases, the compression
element includes a dome-shaped handle disposed on the top end of a
centrally-located rigid connecting stem. Optionally, the bottom end
of the connecting stem can be connected to the top surface of a
generally planar flexible contact pad and define the compressive
area. The handle can include a dome-shaped upper surface and an
annular planar lower surface surrounding the top end of the
connecting stem, and the upper surface and lower surface can be
separated by a peripheral flange. In some cases, a device includes
at least one measuring element associated with the contact pad. A
measuring element can be configured to measure a physiological
parameter of the patient. A device may also include a display
element associated with the contact pad. In some cases, the display
element is configured to provide patient feedback information. A
device may also include at least one electrode associated with the
surface element for applying electricity to the body part. In some
cases, a device includes means associated with the surface element
for applying a drug. Optionally, a device may include at least one
sensor associated with the surface element. In some instances, a
device may include at least one reference element associated with
the surface element to aid in the proper placement of the surface
element on the body part.
In another aspect, embodiments provide systems and methods for
increasing and reducing intrathoracic pressure wherein a flexible
contact pad is removably attached to a patient's chest over a
contact area, and a handle configured to be pressed and lifted is
operably connected to the contact pad so that pressing down of the
handle applies a compressive force over a compressive area to
compress the chest, and lifting up of the handle applies a lifting
force over the contact area to expand the chest. In some cases, the
contact area is sized to be at least twice as large as the
compressive area. Optionally, the contact area is sized to be from
2 to 3 times as large as the compressive area.
In still another aspect, embodiments of the present invention
encompass systems and methods for compressing and expanding a body
part that include, for example, providing a compression element
that is configured to be pressed so as to apply a compressive force
over a compressive area, operably coupling the compression element
with a flexible surface element having a top surface including the
compressive area and a bottom surface, removably attaching the
bottom surface of the surface element to a body part to define a
contact area that is at least twice as large as the compressive
area, pressing the compression element against the surface element
to compress the body part over the compressive area, and lifting
the surface element to actively expand the body part over the
contact area. In some cases, the surface element is a contact pad
attached to a patient's chest with adhesive. In some cases, the
compression element is a handle that is pressed and lifted by hand.
Optionally, the contact area is sized to be in the range of two to
three times as large as the compressive area.
In still another aspect, embodiments of the present invention
encompass systems and methods and devices for the performance of
volume exchange CPR, wherein during the compression of the chest
the pressure inside the thorax rises and blood is propelled forward
out of the heart and lungs to the brain and other organs outside
the thorax. At the same time respiratory gases are pushed out of
the lungs as the lungs are compressed. During the decompression
phase the anterior chest wall is lifted upward and at the same time
respiratory gases are prevented or inhibited from entering the
lungs by transiently blocking or occluding the airway. By
preventing or inhibiting respiratory gases from entering the lungs
during the decompression phase of the thorax, more blood volume is
drawn into the thorax, into the heart and lungs, in exchange for
the volume of respiratory gas that was pushed out of the lungs on
the prior compression and not allowed back into the lungs by
occluding the airway. The means to occlude the airway could be a
one-way valve or preferably a valve system that allows for the
rescuer to ventilate the patient. One way to ventilate the patients
would be to periodically provide a positive pressure ventilation
through or around the one-way valve. Thus, volume exchange CPR
allows for blood flow out of the heart or the brain during the
compression phase, and allows for more blood, rather than
respiratory gases, to enter the lungs during the decompression
phase. In one aspect of volume exchange CPR, respiratory gases
could be actively removed from the lungs with a low-level vacuum
that could be continuous or intermittent, during CPR. In another
aspect of volume exchange CPR respiratory gases could be actively
withdrawn from the lungs and then a positive pressure breath could
be delivered, with or without a period of positive end-expiratory
pressure before or after the positive pressure ventilation.
In another aspect, embodiments of the present invention encompass
systems and methods for applying guided active compression
decompression cardiopulmonary resuscitation to an individual in
need thereof. Exemplary systems may include a handle, a measuring
assembly in operative association with the handle, and an adhesive
pad. The handle and the adhesive pad can be configured for
releasable coupling. In some cases, the measuring assembly includes
a force measuring device. In some cases, the measuring assembly
includes a distance measuring device. In some cases, the measuring
assembly includes a force and distance measuring device.
Optionally, a force and distance measuring device may include an
accelerometer.
In another aspect, embodiments of the present invention encompass
automated systems for applying guided active compression
decompression cardiopulmonary resuscitation to an individual in
need thereof. Exemplary systems may include an automated
compression decompression generation assembly, a measuring assembly
in operative association with the automated compression
decompression generation assembly, and an adhesive pad. The
automated compression decompression generation assembly and the
adhesive pad can be configured for releasable coupling.
In another aspect, embodiments of the present invention encompass
systems and methods for applying guided active compression
decompression cardiopulmonary resuscitation to an individual in
need thereof. Exemplary systems may include a handle, a measuring
assembly in operative association with the handle, and an adhesive
pad. The handle and the adhesive pad can be configured for
releasable coupling via a mechanical interlock. In some instances,
the mechanical interlock includes a ball and socket assembly.
Optionally, a mechanical interlock can include a cantilevered arm
assembly. In some cases, the mechanical interlock includes a detent
mechanism assembly.
In some aspects, embodiments of the present invention encompass
systems and methods for providing a volume exchange cardiopulmonary
resuscitation treatment to a patient. Exemplary methods may include
compressing the patient's chest during a compression phase, and
lifting upward the patient's anterior chest wall and occluding the
patient's airway during a decompression phase. Relatedly, systems
may include means for compressing the patient's chest during a
compression phase, and for lifting upward the patient's anterior
chest wall and occluding the patient's airway during a
decompression phase. In some cases, the step of occluding the
patient's airway includes occluding the airway with a one way
valve. In some cases, the step of occluding the patient's airway
includes occluding the airway with a valve system that allows an
operator to ventilate the patient. Optionally, methods may include
ventilating the patient with the valve system. In some cases,
methods may include ventilating the patient by provide a positive
pressure ventilation through or around the one-way valve. Methods
may also include actively removing respiratory gases from the
patient's lungs with a low-level vacuum. Relatedly, systems may
include means for providing a low-level vacuum. In some instances,
the low-level vacuum is continuous. In some instances, the
low-level vacuum is intermittent. Some methods may include actively
withdrawing respiratory gases from the patient's lungs, and
subsequently delivering a positive pressure breath to the patient.
Related systems may include means for actively withdrawing
respiratory gases from the patient's lungs, and for subsequently
delivering a positive pressure breath to the patient. In some
cases, the positive pressure breath is delivered with a period of
positive end-expiratory pressure, either before or after the
positive pressure ventilation.
In still another aspect, embodiments of the present invention
include systems and methods for providing a volume exchange
cardiopulmonary resuscitation treatment to a patient. Exemplary
systems may include a compression element that is configured to be
pressed and lifted, a flexible surface element operably coupled
with the compression element and configured to be removably
attached to a body part, and an occlusion mechanism for occluding
the patient's airway during a decompression phase. In some
instances, the occlusion mechanism includes a one way valve. In
some instances, the occlusion mechanism includes a valve system
that allows an operator to ventilate the patient. In some
instances, systems may include a vacuum source for actively
removing respiratory gases from the patient's lungs with a
continuous or intermittent low level vacuum.
In another aspect, embodiments of the present invention encompass
systems and methods for actively compressing and expanding an area
of the body. Exemplary devices may include a compression element
that is configured to be pressed and lifted, a flexible surface
element operably coupled with the compression element and
configured to be removably attached to a body part, an interface
for displaying information to and receiving information from an
operator, a processor coupled with the interface, and a memory
coupled with the processor. The memory can be configured to store a
plurality of code modules for execution by the processor. The
plurality of code modules can include a module for recording a
compression event history, a module for storing the compression
event history, a module for assessing a cardiopulmonary
resuscitation quality factor, and a module for providing feedback
to the operator based on the cardiopulmonary resuscitation quality
factor.
In still another aspect, embodiments of the present invention
encompass systems and methods for actively compressing and
expanding an area of the body. Exemplary devices may include a
compression element that is configured to be pressed and lifted, a
flexible surface element operably coupled with the compression
element and configured to be removably attached to a body part, an
interface for displaying instructions to an operator, a processor
coupled with the interface, and a memory coupled with the
processor. The memory can be configured to store a plurality of
code modules for execution by the processor. The plurality of code
modules can include a module for providing operator instructions to
perform a number of compressions prior to initiating active
compression and decompression.
In still a further aspect, embodiments of the present invention
encompass systems and methods for treating a patient. Exemplary
methods may include providing a compression element that is
configured to be pressed so as to apply a compressive force to the
patient's chest, operably coupling the compression element with a
flexible surface element having a top surface and a bottom surface,
removably attaching the bottom surface of the surface element to
the patient's chest, attaching a lower compression device to at
least a portion of a lower extremity of the patient, repetitively
pressing the compression element against the surface element to
compress the patient's chest and lifting the surface element to
actively expand the patient's chest, so that the patient's chest
experiences a compression phase and a recoil phase, and compressing
the person's lower extremity using the lower compression device
during at least some of the recoil phases.
For a fuller understanding of the nature and advantages of the
present invention, reference should be had to the ensuing detailed
description taken in conjunction with the accompanying
drawings.
BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1 illustrates aspects of an ACD CPR system according to
embodiments of the present invention.
FIGS. 1A and 1B illustrate aspects of ACD CPR systems according to
embodiments of the present invention.
FIG. 2 shows aspects of adhesive pad placement on a patient
according to embodiments of the present invention.
FIG. 3 depicts aspects of an adhesive pad according to embodiments
of the present invention.
FIG. 4 provides a block diagram of an exemplary module system
according to embodiments of the present invention.
FIGS. 5A to 5D depict aspects of a magnetic coupling mechanism in
an external chest compression and decompression system according to
embodiments of the present invention.
FIGS. 6A to 6D illustrate features or properties of a load cell or
preload spring mechanism according to embodiments of the present
invention.
FIG. 7 is a perspective top view of a device in accordance with
embodiments of the present invention.
FIG. 8 is a perspective side view of the device shown in FIG.
7.
FIG. 9 is an exploded perspective view of the device shown in FIG.
7.
FIGS. 10A to 10C are schematic illustrations of the device shown in
FIG. 7 in use during the positioning (FIG. 10A), compression (FIG.
10B) and expansion (FIG. 10C) steps of a method according to
embodiments of the present invention.
FIG. 11 is a perspective view of a device in accordance with
embodiments of the present invention.
FIG. 12 is a schematic illustration of a powered automatic system
using a device according to embodiments of the present
invention.
FIG. 13 illustrates aspects of exemplary treatment methods
according to embodiments of the present invention.
FIG. 14 illustrates aspects of exemplary treatment systems
according to embodiments of the present invention.
FIG. 15 illustrates aspects of exemplary treatment systems
according to embodiments of the present invention.
FIG. 16 illustrates aspects of exemplary treatment systems
according to embodiments of the present invention.
DETAILED DESCRIPTION OF THE INVENTION
Systems and methods are provided for performing manual and
automated cardiopulmonary resuscitation (CPR), optionally in
combination with electrocardiographic monitoring (ECM) and/or
electrical defibrillation as part of advanced cardiac life support
(ACLS) procedures. However, it will be recognized by one skilled in
the art that embodiments of the present invention may also find
other uses wherein compression and expansion of a body part or body
area is required or beneficial, optionally in combination with
decompression maneuvers. Therefore, the invention is not intended
be limited to the specific embodiments described herein.
System and method embodiments provided herein are well suited for
administering enhanced ACD CPR and ACLS procedures. Exemplary
systems include a disposable adhesive pad which sticks to the chest
of the patient, a detachable handle that detaches from the adhesive
pad when excessive decompression force (upward pull) is applied,
and a display which indicates to the operator the appropriate
amount of force to be applied. Moreover, systems can be configured
or customized for use on a particular individual based on body
weight or size, for example. In some cases, systems and methods can
be used by rescuers to perform ACD CPR on patients in cardiac
arrest, or in patients showing a lack of signs of circulation.
ACD CPR systems and techniques provided herein can enable a rescuer
or operator to perform ACD CPR, which differs from standard CPR in
that it actively re-expands (decompresses) the chest after each
compression. This approach allows the operator to use the same body
position and compression technique as in standard CPR. Active chest
decompression is achieved when the rescuer maintains a firm grip on
the ACD CPR system and swings his or her body weight upwards after
compression. A single-use disposable adhesive pad can be applied to
the chest and transfers the lifting force to the lower part of the
ribcage. Compression force is transferred to the chest as in
standard CPR via the device's piston and compression pad. A force
gauge in the handle assists the rescuer in applying the force
needed to achieve desired compression (e.g. 11/2 to 2 inches), and
the lift necessary for adequate decompression. A visual metronome
can guide the rescuer to compress and decompress at the appropriate
rate and force.
In use, the operator can attach the system with the patient's chest
via the adhesive pad, and apply compressive and decompressive
forces to the patient by maneuvering the system handle. For
example, the operator can press downwardly on the handle with a
sufficient force so as to compress the patient's chest and induce
blood circulation from the chest. The operator can then pulls
upwardly on the handle so that the adhesive pad actively expands
the patient's chest to induce blood circulation into the chest and
ventilate the patient's lungs. The downward and upward strokes can
be repeated at a rate sufficient to maintain blood circulation and
enhance ventilation, typically with a compression distance in the
range from about 3.5 cm to about 5 cm and a rate in the range from
about 60 repetitions to about 100 repetitions per minute. This
technique may be particularly effective when the operator kneels
beside the patient and grasps the handle with fully-extended arms,
with the operator's palms engaging the upper surface of the handle
and fingers grasped around the peripheral flange of the handle. The
operator may then apply the necessary or desired downward and
upward strokes with fully-extended, locked arms while holding the
system in a very stable configuration.
Turning now to the drawings, FIG. 1 illustrates aspects of an ACD
CPR system according to embodiments of the present invention. The
stem 107 of the system handle 105 contains a load cell 110 that
measures the compression and decompression forces applied to the
patient P. In some embodiments, a load cell 110 which measures the
compression and decompression forces is in compression during its
resting state. Accordingly, the load cell 110 can provide
measurements for both upward and downward forces. The handle 105
can be designed to provide a convenient grip 106 that transfers
compression via the heels of the hand and lift via the fingers.
Hence, no change of grip may be needed between compression and
decompression. The system 100 may be configured so that the handle
105 is automatically positioned by magnets 120, 130 when the handle
105 comes into contact with the adhesive pad 140. According so some
embodiments, system 100 may include a detachable magnetic
connection mechanism 150 disposed between the handle 105 and the
adhesive pad 140. The connection mechanism 150 can be configured so
that the handle 105 decouples from the adhesive pad 140 on the
chest when the decompression force exceeds a predetermined limit.
For example, the handle 105 may become unattached at a pull force
of 25 lbs, thereby not allowing the user to pull up with more than
25 lbs force. Furthermore, the handle 105 can be easily attached to
the adhesive pad 140 when it is brought close to the pad 140 via
the magnetic interlock or connection mechanism 150.
FIG. 1A provides a top view of an ACD CPR system 100a according to
embodiments of the invention. System 100a includes a handle 105a
having two handgrips 110a, 112a and a graphical user interface
120a. Handle 105a is intended for multiple uses and is easily
attached and removed from an adhesive pad 130a. In some cases,
adhesive pad 130a is disposable. For example, in use the adhesive
pad may be applied to a patient during an ACD CPR procedure, and
discarded following the treatment. Handle 105a may be attached with
adhesive pad 130a via a magnet. In some instances, the magnetic
coupling is configured such that handle 105a becomes detached from
adhesive pad 130a when excessive decompression force (upward pull)
is applied. Other means to couple the handle to the adhesive pad
include various mechanical connections including ball and socket,
cantilevered arm, or detent mechanism or the like.
FIG. 1B depicts an exemplary graphical user interface (GUI) 120b
according to embodiments of the present invention. As shown here,
GUI 120b includes a body size input 140b having a small body size
selection 142b, a medium body size selection 144b, and a large body
size selection 146b. These three inputs or buttons allow a user to
select the patient chest size or stiffness. GUI 120b also includes
a target compression/decompression numerical rate display 152b, an
actual or applied compression/decompression numerical rate display
154b, and a power indicator or button 156b. Target rate display
152b can be configured to provide a numerical display or output of
the desired or appropriate compression rate, decompression rate, or
both. Actual rate display 154b can be configured to provide a
numerical display of the actual or applied compression rate,
decompression rate, or both. Further, GUI 120b includes a force
application display 160b that includes a force guide 170b and a
force display 180b.
Force guide 170b provides an indication or guide to the operator of
how hard to push during a chest compression, how hard to pull
during a chest decompression, and how fast to push and pull while
administering the compressions and decompressions. For example, in
some cases the system may determine that a compression force of 100
lbs and a decompression force of 20 lbs should be applied during
the treatment, at a rate of 120 compressions per minute. Table 1
shows an exemplary set of prescribed compression and decompression
forces associated with indicator bars of force guide 170b, for such
treatment parameters. During the compression and decompression
phases of the cycle, indicator bars 171b-178b light up or activate
in sequence at the prescribed rate, to provide the operator with a
visual guide of how forcefully and how quickly to administer the
compressions and decompressions.
TABLE-US-00001 TABLE 1 Indicator Bar Force Time ACD CPR cycle
(compression) 171b 20 lbs 0.025 seconds 172b 40 lbs 0.050 seconds
173b 60 lbs 0.075 seconds 174b 80 lbs 0.100 seconds 175b 100 lbs
0.125 seconds (compression target) 174b 80 lbs 0.150 seconds 173b
60 lbs 0.175 seconds 172b 40 lbs 0.200 seconds 171b 20 lbs 0.225
seconds 0 lbs 0.250 seconds ACD CPR cycle (decompression) 176b 6.7
lbs 0.292 seconds 177b 13.4 lbs 0.333 seconds 178b 20 lbs 0.375
seconds (decompression target) 177b 13.4 lbs 0.416 seconds 176b 6.7
lbs 0.458 seconds 0 lbs 0.500 seconds
Ventilations can be provided to the patient, for example according
to current American Heart Association recommendations. In some
cases, ventilations can be administered to the patient at a
compression-ventilation ratio of about 30:2 (i.e. 30 chest
compressions given for every two rescue breaths).
Force display 180b provides an indication of how hard the operator
is actually pushing during the compression phase and pulling during
the decompression phase, and how fast the operator is pushing and
pulling when administering the compressions and decompressions. For
example, during the compression and decompression phases of the
cycle, indicator bars 181b-188b light up or activate depending on
how forcefully and how quickly the operator administers the
compressions and decompressions. Accordingly, force display 180b
enables the operator to track or visualize his or her actual
applied force and rate, and compare the applied force and rate with
the target force and rate as provided by force guide 170b. By using
force guide 170b as a target reference and force display 180b as an
indication of the efforts applied during treatment, the operator
can realize or approach the goal of matching the applied forces and
rates with the target forces and rates.
Force application display 160b also includes a decompression
indicator 162b, a compression indicator 164b, a decompression limit
warning indicator 166b, and a compression limit warning indicator
168b. According to the embodiment depicted here, decompression
indicator 162b provides the user with a reference or indication
that force guide 170b and force display 180b signals displayed
toward the top of GUI 120b are associated with the decompression
phase of ACD CPR. Likewise, compression indicator 164b provides the
user with a reference or indication that force guide 170b and force
display 180b signals displayed toward the bottom of GUI 120b are
associated with the compression phase of ACD CPR. The system can be
configured so that decompression limit warning indicator 166b
lights up or activates when the operator applies a decompression
force that exceeds a prescribed decompression force or force range.
Similarly, system can be configured so that compression limit
warning indicator 168b lights up or activates when the operator
applies a compression force that exceeds a prescribed decompression
force or force range. These features can help the operator avoid
application of excessive forces during treatment, which in some
cases could cause injury to the patient.
In some cases, red caution lights may illuminate when the applied
force exceeds the prescribed force range. For example, if the
operator approaches or exceeds the decompression target limit, a
caution light may illuminate and the handle can disconnect from the
adhesive pad either immediately or shortly thereafter. In the event
the handle becomes detached, the rescuer may reattach the handle by
bringing the handle close to the adhesive pad, whereby the handle
and the adhesive pad are coupled via magnetic attraction. Once the
handle and the pad are attached, the operator can resume the
compression and decompression actions of the ACD CPR method. The
rescuer can avoid or minimize frequent handle detachment by
following the direction provided by a force guide.
When preparing the system for use on a patient, the operator can
power on the system by pushing the power button 156b. According to
some embodiments, the lights on the right side of the display will
illuminate in response to activation of the power switch. In some
cases, the operator may take caution not to push on the chest when
pressing the power button. For example, in order for the force
gauge to appropriately calibrate, it may be beneficial to have no
load placed on the handle when the system is initially powered
on.
ACD CPR systems disclosed herein may be operated in any of a
variety of ways. For example, in one exemplary method, the operator
uses the system to initially compress the chest about 11/2 to about
2 inches and hold the compression for about 2 seconds. During this
time, the system can measure the applied force and determine the
target force automatically. In this sense, the target force
corresponds to an amount of force applied so as to compress the
chest about 11/2 to about 2 inches. It is understood that the
target force may be set at a different amount by initially
compressing the chest to a different distance. Hence, the initial
compression distance can determine the target force. The system may
also indicate the patient's chest size by illuminating the
appropriate button. In this case, the user does not have to select
the chest compliance, and the system automatically determines the
amount of force required to compress the patient's chest by 11/2 or
2 inches. However, at any time the user can push a desired body
size input (e.g. 142b, 144b, or 146b) so as to select an alternate
size/compliance and the target force will update to the selected
size.
In another exemplary method, the operator may manually select the S
(142b), M (144b), or L (146b) chest size on the handle by pressing
the appropriate button of the body size input 140b. The system can
recognize that the user has selected a predefined force target and
then guide the user accordingly. In some embodiments, the target
force values are as depicted in Table 2 below.
TABLE-US-00002 TABLE 2 Patient Chest Size Force Range (Compression)
Small Adult Chest 60-80 lbs Medium or Average Adult Chest 80-95 lbs
Large Adult Chest 95-115 lbs
As noted elsewhere herein, in some embodiments caution lights 166b,
168b may illuminate when the applied force exceeds the prescribed
force range. At any time, the operator can change the force target
by pushing an alternate chest size or body size input 140b. In this
way, the operator may determine the appropriate force target during
a rescue treatment, and such adjustments may be made on the fly.
For example, there may be instances where a small chest is
extremely rigid and may require more than 80 lbs for effective CPR.
In some cases, during CPR the chest may become more compliant, and
hence it may be desirable to use less force if the rescuer feels
that the chest is being compressed excessively, for example by more
than about 2 inches.
In yet another exemplary method, the rescuer may simply start
compressions by following the pacing guide as provided by the
system itself. The system can be configured to default to a target
compression force associated with the medium body size selection
144b or the average adult chest size, and the compression force
delivered will be targeted within a range from about 80 to about 95
lbs, for example. In some cases, the decompression force target can
be set at a fixed value (e.g. 20 lbs), regardless of chest size.
Optionally, the decompression force target can be set at a value
that is a function of chest or patient size, or compliance.
In many instances, it is beneficial for the operator to compress
the chest a certain number of times (e.g. about 30) without
actively pulling up beyond neutral or applying a decompression
force, to ensure appropriate adhesion of the adhesive pad before
beginning active decompressions. Hence, the system can be
configured or programmed to illuminate the guiding light or force
guide 170b so as to guide the user to perform a certain number of
compressions (e.g. about 30) before beginning ACD CPR. For example,
the force guide 170b may initiate a series of signal displays for
indicators 171b-175b (compression phase), but not for indicators
176b-178b (decompression phase). When the predetermined number of
compressions are complete, the guiding light or force guide 170b
can then direct the operator to compress and decompress in
accordance with ACD CPR procedures.
According to some embodiments of the present invention, the
decompression force target may be set to a predetermined value
(e.g. 20 lbs), regardless of chest size. If the operator exceeds
the decompression target limit, a caution light 166b may illuminate
and the handle can disconnect from the adhesive pad either
immediately or shortly thereafter. In the event the handle becomes
detached, the rescuer may reattach the handle by bringing the
handle close to the adhesive pad, attaching the handle and pad via
magnetic attraction, and resuming ACD CPR. The rescuer can avoid or
minimize frequent handle detachment by following the direction
provided by force guide 170b.
Exemplary system embodiments may include a timer. For example, a
system may include a timer display on the graphical user interface.
A timer can be configured to keep a running count of the amount of
time (e.g. number of minutes) the system has been powered on, and
can be used as a guide to time medication administration or rescuer
rotation. To avoid fatigue, it may be beneficial for multiple
rescuers to take turns performing the compression/decompressions,
changing every 2 to 3 minutes.
When the system is in place on the patient, the rescuer can kneel
close to the patient's side. For optimal position, shorter rescuers
may find it beneficial to elevate themselves slightly by kneeling
on padding. If the patient is in bed (with hard surface under
torso), it may be helpful for the rescuer to kneel next to the
patient or stand on a platform of sufficient height. When the
rescuer is appropriately positioned, he or she can grab the system
handle with both hands, placing the heels of their hands on the
handle grips or palm pads with wrists bent. The rescuer can then
compress and decompress with their shoulders directly over the
sternum with arms outstretched and elbows locked. The rescuer may
use the large muscles in their thighs to lift and compress, bending
at the waist.
According to some embodiments, the system can be configured to
provide a soft start in which the initial target compression forces
are not as high as the target compression forces encountered later
on during CPR.
FIG. 2 shows an example of adhesive pad placement on a patient,
according to embodiments of the present invention. As depicted
here, an adhesive pad 210 is placed on patient 200, such that a
nipple line 220 of pad 210 extends between the patient's nipples
202a, 202b. Further, adhesive pad 210 is placed such that sternum
notch 230 of pad 210 is placed in the center of the patient's
chest, directly over the sternum. Adhesive pad 210 may have a
sternum line 240 which can be placed in alignment with the
patient's sternum. When applying the system to the patient, the
operator may orient the system such that the compression point of
the system, which can be aligned with an adhesive pad compression
point 250, is on the lower half of the sternum or center of the
chest, which is at or near the compression point as prescribed in
manual CPR techniques.
FIG. 3 illustrates an adhesive pad 300 according to embodiments of
the present invention. Adhesive pad 300 includes a nipple line 320
which can be placed in alignment with the patient's nipples, and a
sternum notch 330 that can be aligned with the patient's sternum.
As shown here, adhesive pad 300 may include a liner 360 and an
adhesive face 370. When applying the adhesive pad 300 to the
patient, the operator may peel or remove liner 360 of the adhesive
pad away from adhesive face 370, and place adhesive face 370 toward
the patient's chest, for example on the sternum at the mid-nipple
line as indicated on the adhesive pad shown in FIGS. 2 and 3.
When administering an ACD CPR treatment to an individual, it may be
helpful to assess the condition of the patent prior to the
treatment. In some cases, it may be desirable to determine that
patient exhibits no signs of circulation, such as consciousness,
breathing, coughing, movement, pulse, or the like. Such assessments
may be performed according to local standards.
The system can be turned off after use by pressing and holding down
the power button for a predetermined amount of time, for example 5
seconds. During this time, the timer may display the battery life
remaining in hours. If the power button is not held for a
sufficient amount of time (e.g. 5 seconds) the system may remain
on, but may automatically power off after 5 minutes if no
compressions are sensed. The handle can be configured to provide a
predetermined number of hours of use. For example, the handle can
be designed to provide about 30 hours of use. At any time, the user
can determine the remaining battery life by pressing and holding
the power button. The timer can display the amount of time
remaining, for example by displaying the letter H followed by a
number. The number can indicate the number of hours of battery life
remaining. Optionally, the system can be configured so that when
there is less than one hour of battery life remaining, the rate
display will begin flashing whenever the device is turned on. In
some embodiments, when battery life is depleted, the unit will not
power up. Optionally, the handle can then be returned to the
manufacturer and the unit will be refurbished and a new battery
supplied.
FIG. 4 is a simplified block diagram of an exemplary module system
that broadly illustrates how individual system elements for a
module system 400 may be implemented in a separated or more
integrated manner. Module system 400 may be part of or in
connectivity with an ACD CPR system according to embodiments of the
present invention. Module system 400 is well suited for receiving
input or information from an operator, a patient, or both, and for
displaying output or information as part of an ACD CPR treatment.
Module system 400 as shown here includes hardware elements that are
electrically coupled via a bus subsystem 402, including one or more
processors 404, one or more input devices 406 such as user
interface input devices, one or more output devices 408 such as
user interface output devices, a network interface 410, and a load
system interface 440 that can receive signals from and transmit
signals to load system 442.
In some embodiments module system 400 also comprises software
elements, shown as being currently located within working memory
412 of memory 414, including an operating system 416 and other code
418, such as a program designed to implement methods of the
invention.
Likewise, in some embodiments module system 400 may also include a
storage subsystem 420 that can store the basic programming and data
constructs that provide the functionality of the various
embodiments of the present invention. For example, software modules
implementing the functionality of the methods of the present
invention, as described herein, may be stored in storage subsystem
420. These software modules are generally executed by the one or
more processors 404. In a distributed environment, the software
modules may be stored on a plurality of computer systems and
executed by processors of the plurality of computer systems.
Storage subsystem 420 can include memory subsystem 422 and file
storage subsystem 428. Memory subsystem 422 may include a number of
memories including a main random access memory (RAM) 426 for
storage of instructions and data during program execution and a
read only memory (ROM) 424 in which fixed instructions are stored.
File storage subsystem 428 can provide persistent (non-volatile) or
non-transitory storage for program and data files, and may include
tangible storage media which may optionally embody patient,
treatment, assessment, or other data. File storage subsystem 428
may include a hard disk drive, a floppy disk drive along with
associated removable media, a Compact Digital Read Only Memory
(CD-ROM) drive, an optical drive, DVD, CD-R, CD RW, solid-state
removable memory, other removable media cartridges or disks, and
the like. One or more of the drives may be located at remote
locations on other connected computers at other sites coupled to
module system 400. The modules implementing the functionality of
the present invention may be stored by file storage subsystem 428.
In some embodiments, the software or code will provide protocol to
allow the module system 400 to communicate with communication
network 430. Optionally, such communications may include dial-up or
internet connection communications.
It is appreciated that system 400 can be configured to carry out
various aspects of methods of the present invention. For example,
processor component or module 404 can be a microprocessor control
module configured to receive physiological, device, or treatment
parameter signals from sensor input device or module 432 or user
interface input device or module 406, and to transmit treatment
signals to output device or module 436, user interface output
device or module 408, network interface device or module 410, or
any combination thereof. Each of the devices or modules according
to embodiments of the present invention can include one or more
software modules on a computer readable medium that is processed by
a processor, or hardware modules, or any combination thereof. Any
of a variety of commonly used platforms, such as Windows,
Macintosh, and Unix, along with any of a variety of commonly used
programming languages, may be used to implement embodiments of the
present invention.
User interface input devices 406 may include, for example, a
touchpad, a keyboard, pointing devices such as a mouse, a
trackball, a graphics tablet, a scanner, a joystick, a touchscreen
incorporated into a display, audio input devices such as voice
recognition systems, microphones, and other types of input devices.
User input devices 406 may also download a computer executable code
from a tangible storage media or from communication network 430,
the code embodying any of the methods of the present invention. It
will be appreciated that terminal software may be updated from time
to time and downloaded to the terminal as appropriate. In general,
use of the term "input device" is intended to include a variety of
conventional and proprietary devices and ways to input information
into module system 400.
User interface output devices 406 may include, for example, a
display subsystem, a printer, a fax machine, or non-visual displays
such as audio output devices. The display subsystem may be a
cathode ray tube (CRT), a flat-panel device such as a liquid
crystal display (LCD), a projection device, or the like. The
display subsystem may also provide a non-visual display such as via
audio output devices. In general, use of the term "output device"
is intended to include a variety of conventional and proprietary
devices and ways to output information from module system 400 to a
user.
Bus subsystem 402 provides a mechanism for letting the various
components and subsystems of module system 400 communicate with
each other as intended. The various subsystems and components of
module system 400 need not be at the same physical location but may
be distributed at various locations within a distributed network.
Although bus subsystem 402 is shown schematically as a single bus,
alternate embodiments of the bus subsystem may utilize multiple
busses.
Network interface 410 can provide an interface to an outside
network 430 or other devices. Outside communication network 430 can
be configured to effect communications as needed or desired with
other parties. It can thus receive an electronic packet from module
system 400 and transmit any information as needed or desired back
to module system 400. In addition to providing such infrastructure
communications links internal to the system, the communications
network system 430 may also provide a connection to other networks
such as the internet and may comprise a wired, wireless, modem,
and/or other type of interfacing connection.
It will be apparent to the skilled artisan that substantial
variations may be used in accordance with specific requirements.
For example, customized hardware might also be used and/or
particular elements might be implemented in hardware, software
(including portable software, such as applets), or both. Further,
connection to other computing devices such as network input/output
devices may be employed. Module terminal system 400 itself can be
of varying types including a computer terminal, a personal
computer, a portable computer, a workstation, a network computer,
or any other data processing system. Due to the ever-changing
nature of computers and networks, the description of module system
400 depicted in FIG. 4 is intended only as a specific example for
purposes of illustrating one or more embodiments of the present
invention. Many other configurations of module system 400 are
possible having more or less components than the module system
depicted in FIG. 4. Any of the modules or components of module
system 400, or any combinations of such modules or components, can
be coupled with, or integrated into, or otherwise configured to be
in connectivity with, any of the treatment system embodiments
disclosed herein. Relatedly, any of the hardware and software
components discussed above can be integrated with or configured to
interface with other medical assessment or treatment systems used
at other locations.
In some embodiments, the module system 400 can be configured to
receive a physiological parameter of the patient at an input
module. Physiological parameter data can be transmitted to an
assessment module where a physiological profile is determined. The
profile can be output to a system user via an output module. In
some cases, the module system 1300 can determine a treatment
protocol for the patient, based on a physiological parameter or
profile, for example by using a treatment module. The treatment can
be output to a system user via an output module. Optionally,
certain aspects of the treatment can be determined by an output
device, and transmitted to a treatment system or a subdevice of a
treatment system. Any of a variety of data related to the patient
can be input into the module system, including age, weight, sex,
treatment history, medical history, and the like. Parameters of
treatment regimens or diagnostic evaluations can be determined
based on such data.
FIGS. 5A to 5D depict aspects of an exemplary magnetic coupling
mechanism in an external chest compression and decompression
system. FIG. 5A provides a top view of compression and
decompression system 500. FIG. 5B provides a cross-section view of
compression and decompression system 500, which includes a handle
assembly 510 releasably coupled with an adhesive pad assembly 520.
As shown here, system 500 may include a coupling mechanism 530
between a disposable adhesive pad 520 and a system handle 510. The
coupling mechanism 530 can include a magnet 540 and a magnet keeper
550. In some cases, as depicted in FIG. 5C, a magnet 540c may
include or be part of a magnet assembly 560c having a magnet 540c,
a non-ferrous spacer 542c, and a ferrous container 544c for
directing the magnetic flux from the pole of the magnet furthest
away from the magnet keeper to the magnet keeper. The poles of the
magnet can be arranged such that the poles are aligned along the
axis 580 of the system piston 570. As shown in FIG. 5D, a magnetic
keeper 550d on the disposable adhesive pad assembly 520d of system
500d can include a magnet 552d with poles arranged in the opposite
direction of the system handle magnet 540d or of a ferrous material
such as 12L14 carbon steel having a high capacity for carrying
magnetic flux. A magnetic coupling between system handle assembly
510d and adhesive pad assembly 520d can be made quickly. Relatedly,
the amount of effort involved with establishing a magnetic coupling
is typically less than the effort involved with disengaging the
magnetic coupling. Further, the force of the disconnection of the
magnetic coupling can be stable over a wide range of operating
environments.
According to some embodiments, a magnetic coupler mechanism can
include a magnet assembly disposed on or coupled with a handle, and
a keeper assembly disposed on or coupled with a pad. For example, a
magnetic coupler mechanism 530d as shown in FIG. 5D may include
magnet 540d, or magnet assembly (such as magnet assembly 560c shown
in FIG. 5C), and keeper assembly 550d. The magnet 540d or magnet
assembly can be coupled with or part of system handle assembly
510d. Keeper assembly 550d can be coupled with or part of adhesive
pad assembly 520d. The magnet assembly and keeper assembly in
combination may be referred to as a coupler assembly. In some
cases, the coupler assembly can operate to provide a consistent
release force allowing the handle to separate from the pad prior to
the pad releasing from the patients skin. In addition, it may be
desirable that the magnet assembly does not have a magnetic field
that is widely dispersed, but rather focused in the direction of
the keeper. To focus the magnetic field, the magnet assembly can
include a magnetic core, a non-magnetic sleeve, and a ferromagnetic
pot which conducts the magnetic flux from the pole on the enclosed
side of the magnet to the open side of the magnet. The arrangement
of a jacket with the magnet can focus the majority of the magnetic
flux to the open end of the assembly. For example, as shown in FIG.
5C, magnet assembly 560c may include a magnetic core 540c, a
non-magnetic sleeve 542c, and a ferromagnetic pot 544c which
conducts the magnetic flux from the pole on the enclosed side 540c'
of the magnet to the open side 540c'' of the magnet. The
arrangement of a jacket 544c with the magnet can focus the majority
of the magnetic flux to the open end of the assembly 560c. Control
or selection of the material properties of the keeper 550d can be
helpful to achieve a consistent release force. In some cases, the
material can have a high magnetic saturation such as a 12L14 or
AISI 1010 or 1020 material and the magnetic properties of the
material can be controlled through the control of material temper.
For example, materials can be processed to a fully annealed
condition.
In addition to the magnetic coupling mechanism described herein,
other types of breakaway mechanisms can be used in an external
chest compression and decompression for coupling a disposable
adhesive pad with a system handle. Exemplary breakaway mechanisms
can be configured to allow the handle to disengage from the pad in
a controlled manner.
FIGS. 6A to 6C illustrate features of an exemplary load cell or
preload spring mechanism, according to embodiments of the present
invention. FIG. 6A provides a top view of compression and
decompression system 600. FIG. 6B provides a cross-section view of
compression and decompression system 600, which includes a handle
assembly 610 releasably coupled with an adhesive pad assembly 620.
As shown here, system 600 may include a coupling mechanism 630
between a disposable adhesive pad 620 and a system handle 610. The
coupling mechanism 630 can include a load cell assembly 645 and a
preload spring assembly 655. Such load cell or spring mechanisms
can be incorporated in a system for performing external chest
compressions and decompressions. In some cases, a baseline level of
compression can be applied to the load cell via a preload spring.
The preload spring can apply enough force to a device piston in a
direction simulating compression such that the device piston is in
kept in contact with the load cell throughout the
compression/decompression cycle. For example, as shown in FIG. 6C,
system 600c includes a handle assembly 610c, a load cell assembly
645c, a preload spring assembly 655c having a spring 656c, a magnet
assembly 660c for releasable coupling with a keeper assembly of a
pad assembly. System 600c also includes a spacer mechanism 665c in
operative association with spring assembly 655c or spring 656c and
magnet assembly 660c. In some cases, spacer mechanism 665c includes
a post 666c coupled with a shoulder mechanism 667c such as a disc.
System 600c may also include a fastener 668c or fastener means for
fixedly attaching disc 667c, post 666c, and magnet 660c. Hence, the
disc, post, and magnet may operate in unison, such that compression
or decompression force applied to the magnet can be transmitted to
the disc, and vice versa. As depicted in FIG. 6C, load cell 645c
can contact spacer mechanism 665c or piston at a contact point
675c. Preload spring 656c can operate to maintain or facilitate
contact between magnet 660c and load cell 645c, for example via
spacer mechanism 665c. Optionally, the use of the preload spring
may eliminate a need for independent sensors for both compression
and decompression.
According to some embodiments, both compression and decompression
forces can be measured with a load cell. To accomplish measuring
decompression forces the handle can include an internal spring
mechanism that creates a compressive load on the load cell when the
handle is experiencing no external loading. The internal spring
mechanism can apply a compressive force to the load cell at certain
times or periods. For example, the internal spring mechanism can
apply a compressive force to the load cell at all times or at
substantially all times. The handle can include a means of
compensation for this initial compressive force. Compensation for
the internal spring mechanism can be accomplished by zeroing the
load cell output, in software, upon each startup which can
eliminate or reduce effects of sensor and spring force drift due to
age, temperature, or other sources.
The graph in FIG. 6D shows exemplary relationships between (a) the
force that is applied to the system handle and transferred at least
in part to the patient, for example via the magnet [x-axis], and
(b) the force transferred to the load cell [y-axis]. Positive
forces are compressive and negative forces are decompressive. This
graph illustrates the effect of preload application on the load
cell, and shows how a preload spring can condition the forces
applied to the magnet prior to transmission to the load cell. As
depicted in this embodiment, the force on the magnet can be in a
range between about -60 lbs to about 110 lbs, and the force
transferred to the load cell can be in a range between about 0 lbs
and about 150 lbs. Systems can be configured to provide any of a
variety of force profiles, as desired. According to this graph, a
preload mechanism, such as a preload spring assembly, allows the
load cell to measure decompressive forces. The force at the magnet
can be the same or substantially the same as the force at the
handle, which can also be equivalent to the force applied to the
patient, for example where the handle is considered a rigid
mechanism. According to some embodiments, the load cell or force
sensor, which may be present in the handle or at another location
in the system, may be configured to measure or sense compressive
forces. In some instances, the system may be configured so that the
preload spring or mechanism applies a compressive force to the load
cell at all times.
Two load cell configurations are depicted in FIG. 6D. The dashed
line represents a load cell or force profile without a preload
spring or mechanism, and the solid line represents a load cell or
force profile with a preload spring or mechanism. In the particular
embodiment depicted here, the amount of preload is 40 lbs. In
various embodiments, any amount of preload can be selected as
desired. In the dashed line profile, where a preload spring or
mechanism is not present, the force on the load cell is zero when
the handle is pulled up, for example during the decompression
phase. In some cases, a device may not have the capability to
measure decompressive forces unless preload is provided. In the
solid line profile, where a preload spring or mechanism is present,
there is 40 lbs of preload force applied to the load cell in the
absence of force applied to the handle. Hence, the preloaded
configuration allows measurement of decompressive forces, for
example up to the amount of the preload force. In some embodiments,
the preload mechanism may include a coil spring. Optionally, a
preload mechanism may include a Belleville washer. In some cases,
preload can be provided by a resilient housing material, or
otherwise built into the housing element in which the preload is
applied by the resilience of the housing material. According to
some embodiments, preload can be provided by preload mechanisms
that include rubber, an elastomeric substance, fluid, or other
compressible materials or assemblies.
In some instances, guided ACD CPR systems and methods can involve
the use of a load cell in conjunction with an accelerometer. The
load cell can provide a means of measuring active decompression and
an auto zeroing of the accelerometer. The accelerometer can provide
a direct measurement of chest wall displacement in techniques
involving, for example, a 1.5 to 2.0 inch displacement.
Exemplary system and method embodiments may provide treatment with
particularly effective compressive area and contact area
configurations. For example, a device contact area or adhesive pad
can be 2 to 4 times larger than the compressive area. Beneficially,
a large contact area can make it easier for a user or operator to
generate a full or greater decompression resulting in more blood
flow back to the heart. This may be a result of the ability of a
large contact area to physically raise or lift a corresponding
large area of the patient's chest during a decompression maneuver.
Moreover, a sufficiently large compression surface area can allow
the operator or user to provide enhanced coronary perfusion
pressure or more blood flow from the heart to other tissue or
organs during compression, thus improving the likelihood of a
successful medical outcome for the patient such as the return of
spontaneous circulation. According to some embodiments, the systems
and methods discussed herein can be used without preventing lateral
displacement of the chest. For example, these techniques can be
used without binding or constricting the chest with a CPR band
device, or otherwise without applying a circumferential device to
the patient.
Accordingly, embodiments of the present invention provide systems
and methods for actively compressing and expanding an area of the
body that involve a compression element operably coupled to a
flexible surface element that is adapted to be removably attached
to a body part over a contact area. The compression element is
configured to be alternately pressed and lifted, thereby pressing
upon and lifting the surface element. When the compression element
is pressed, it applies a compressive force over a compressive area
of the surface element and the body part to which it is attached.
When the compression element is lifted, the contact area of the
body part attached to the surface element is lifted by the surface
element.
In one embodiment, the device may be used to compress and expand
the thoracic cavity or chest, and to transform the chest into an
active bellows. The increased active expansion of the chest which
occurs when the surface element is lifted causes unexpectedly
enhanced negative pressure within the intrathoracic region
("negative ITP"), thereby drawing a larger amount of air into the
lungs to more effectively ventilate the patient than previous
devices. Accordingly, the device may be used to enhance the
expansion of the chest and resultant lowering of negative ITP for a
variety of purposes, e.g. to perform active
compression/decompression CPR, to treat low blood pressure, to
increase blood circulation, and the like. It has been found that
the larger the body contact area provided by the surface element,
the lower the negative ITP that can be achieved using the device if
the chest is compliant or if a rib has been broken. In exemplary
embodiments, the body contact area provided by the lower surface of
the surface element can be between about two and about four times
greater than the compressive area to which compressive force is
applied on the upper surface of the surface element. Body contact
areas less than the specified range may result in unsatisfactory
expansion of the chest, excessive forces that are concentrated on a
small area (which could damage the skin), and provide less than
optimal negative ITP, whereas body contact areas more than the
specified range can result in unsatisfactory compression of the
chest.
The device may be used in both manual and powered systems. In a
powered system, the compression element may be attached to a
mechanical drive element, such as a mechanical link which is part
of a powered automatic drive system which accomplishes the up and
down motions of the compression and expansion strokes. In a manual
system, the compression element may comprise a handle that can be
grasped by the operator's hands and moved up and down to accomplish
the required or prescribed strokes.
In one embodiment, the device includes a mushroom-shaped
compressive element having a dome-shaped handle disposed on the top
end of a centrally-located rigid connecting stem. The bottom end of
the stem is connected to the top surface of a generally planar
flexible contact pad and defines a compressive area. The lower
surface of the contact pad may be covered with an adhesive adapted
to adhere to the anterior surface of a patient's chest and defines
a contact area. The handle's dome-shaped upper surface is separated
from an annular planar lower surface by a peripheral flange,
thereby allowing an operator to grasp the handle with the palms of
both hands positioned on the upper surface, the fingers curled
around the peripheral flange and the finger tips positioned against
the lower surface.
According to certain method embodiments, the increased negative
intrathoracic pressures of a patient may be effected using the
device generally described herein. After positioning both hands on
the handle, the operator may apply downward force against the
handle with the palms of the hands. The downward force is
transferred through the connecting stem to a compressive area of
the contact pad which is generally defined by the cross-sectional
area of the lower end of the connecting stem. The device may be
positioned on the anterior surface of a patient's chest so that the
compressive area is generally positioned over the patient's
sternum. The downward force compresses the patient's chest over the
compressive area and increases ITP sufficiently to induce blood
circulation from the chest. Then, the operator may lift up the
handle with the fingers under the lower surface of the handle to
provide an upward force on the connecting stem, which in turn moves
the top surface of the contact pad in an upward direction. Since
the contact pad is adhered to the patient's chest across the entire
contact area covered by the contact pad, the upward movement of the
contact pad actively expands the patient's chest. This expansion
reduces ITP to induce blood circulation into the chest and
ventilates the patient's lungs. The downward and upward strokes are
repeated at a rate sufficient to maintain blood circulation and
enhance ventilation, typically with a compression distance in the
range from about 3.5 cm to 5 cm and a rate in the range of 60
repetitions to 100 repetitions per minute.
The devices and methods described herein have been found to be
particularly useful in manual CPR when the performer kneels beside
the patient and grasps the handle with fully-extended arms, with
the performer's palms engaging the upper surface of the handle and
fingers grasped around the peripheral flange of the handle. The
performer may then apply the necessary downward and upward strokes
with fully-extended, locked arms while holding the device in a very
stable configuration.
In some cases, the compression element connected to the upper
surface of the surface element may be attached to a mechanical
drive element, such as a mechanical link which is part of a powered
automatic drive system. In this way, active automatic compression
and expansion of the patient's chest can be performed.
FIGS. 7-9 illustrate aspects of a device embodiment which can be
used for manual operation. The same numbers appearing in these
different figures refer to the same elements. Device 700 comprises
a mushroom-shaped interface element 701 having a handle 702
operably connected through a connecting stem 703 to upper surface
705 of a flexible contact pad 704.
Contact pad 704 may be constructed from a layer of suitable
resilient material such as a natural or synthetic foam. All or a
substantial part of a lower surface 706 may be covered with
adhesive material suitable for adhering contact pad 704 to the
anterior surface of a patient's chest 710. The dimensions of
contact area 707 are defined by the "footprint" of contact pad 704
that is adhered to the patient's chest 710 (or other body
locations). Suitable adhesive materials may include
pressure-sensitive adhesives such as those which are commonly used
on medical bandages, transdermal patches, and other medical
applications. Other useful adhesives may include natural and
synthetic rubber-based formulations, such as polyisobutylenes, and
acrylic and silicon-based materials. Swollen hydrogels, such as
poly(vinyl pyrrolidone), may be suitable when used in conjunction
with electrodes, as described hereinafter. When use of device 700
is completed, contact pad 704 may be removed by conventional means,
e.g. by applying a solvent to the adhesive, simply pulling the pad
away from the chest, and the like.
The dimensions of contact pad 704 can be chosen to provide a
desired contact area 707. In accordance with embodiments of the
invention, the larger that contact area 707 is relative to
compressive area 712, the more expansion of chest 710 can be
achieved using device 700 if the chest is compliant or if a rib has
been broken, for example. For example, if the dimensions of pad 704
are 8''.times.10'' and the operator applies a compressive force on
handle 702 across compressive area 712 having dimensions of
3''.times.3'', chest 710 is subject to greater upward force (and
therefore lower negative ITP) than if the dimensions of pad 704 are
4''.times.6''.
Typically, for adult patients, contact pad 704 will have a
generally square or rectangular shape. For children, the dimensions
may be in considerably smaller. Other shapes may also be useful, it
being necessary only that contact pad 704 be shaped to provide for
a desired force distribution over compressive area 712 as well as
provide for contact area 707 to be at least twice to four times as
large as compressive area 712 so that improved negative ITP in
accordance with the invention can be achieved. For example, it may
be desirable to shape the lower surface 706 of contact pad 704 to
conform to the general contours of the patient's chest 710. In
addition, it may be desirable to provide a plurality of sizes and
shapes of contact pad 704 in a single kit so that a contact pad may
be selected for the individual patient.
The thickness of contact pad 704 may depend on the resiliency of
the material employed. For manual operation, an exemplary thickness
for contact pad 704 is about 3/16''.
Handle 702 comprises dome-shaped upper surface 708 and an annular
planar lower surface 709 separated by peripheral flange 710. The
top of stem 703 is centrally located within annular lower surface
709 of handle 702 and the bottom of stem 703 is centrally located
on the planar upper surface 705 of contact pad 704. The
cross-section of bottom end 713 of stem 703 defines the dimensions
of compressive area 712. The shape of handle 702 allows the
operator's hands 711 to grasp handle 702 with the palms resting on
upper surface 708, the fingers wrapped around ridge 717 and the
finger tips positioned against lower surface 709 (FIG. 8). This
arrangement allows the operator to press down on upper surface 708
of handle 702 with the palms of the hands 711 to apply a
compressive force against pad 704 and patient's chest 710 over a
compressive area 712. The arrangement also allows the operator to
lift up on lower surface 709 of handle 702 with the fingers of
hands 711. Since lower surface 706 of pad 704 is adhered to contact
area 707 of patient's chest 710, this lifting motion on handle 702
lifts and expands patient's chest 710 across contact area 107.
Handle 702 and connective stem 703 may be constructed from a
suitable rigid material, e.g. a molded plastic. Handle 702 may also
be filled with a gel, foam, padding or the like to enhance its
shock-absorbing and distributing capability.
Referring now to FIGS. 10A-10C, use of the device in resuscitating
a patient will be described. The device is initially placed on the
anterior surface of the patient's chest about mid-sternum, as
illustrated in FIG. 10A. The operator then grasps handle 702 with
both hands, as shown in FIG. 8, pressing the palms of the hands 711
against upper surface 708 while grasping the peripheral flange 710
with the fingers. The operator applies sufficient downward force on
handle 702 through stem 703 so that the chest is compressed within
compressive area 712, as shown in FIG. 10B. Typically a compressive
force is used to depress the chest. Contact pad 704, coupled to
stem 703, may be formed of a suitably resilient material, for
example, silicone rubber, which softens the application of downward
force through the stem 703 across compressive area 712. The initial
position of the patient's chest is illustrated in broken line in
FIG. 10B. During the compression stroke, the chest is compressed
across compressive area 712 to the position illustrated in solid
line in FIG. 10B.
After the compression stroke is completed, the operator raises up
on the handle 702 to expand the chest, as illustrated in FIG. 10C.
Again, the rest position of the chest is illustrated in broken line
and the expanded position is shown in solid line. During the chest
expansion stroke, the upward movement of handle 702 through stem
703 raises contact pad 704, which is adhered to the chest across
contact area 707. The chest is pulled upward with contact pad 704
to cause the desired chest expansion. Handle 702 may be raised in
an amount sufficient to apply an expansion force. The compression
and expansion steps may be alternated at a rate in the range from
about 80 to 100 per minute. As previously explained, the larger
contact area 707 is relative to compressive area 712, the more
chest expansion (and negative ITP) that can be achieved with each
stroke. As further described elsewhere herein, and as shown in FIG.
10C, an active compression decompression cardiopulmonary
resuscitation device 700 may be used in conjunction with, or may be
part of a system 750 which includes, a device 760 for providing,
facilitating, or modulating patient airway pressure, such as an
impedance threshold device (ITD) mechanism or an intrathoracic
pressure regulator (ITPR) mechanism. In some cases, device 760 may
include a mechanism, such as a one-way valve, for occluding the
patient's airway during a decompression phase. Device 760 may be
used during any portion of, or throughout the entirety of, a
treatment protocol, for example during one or more of the steps
illustrated in FIGS. 10A-C, or in conjunction with any other method
or system described herein.
It may be desirable to provide at least one element associated with
the device that can measure a physiological parameter and/or
display patient status information and/or feedback to the person
performing the CPR. Preferably, the measuring element is associated
with the surface element. Examples of physiological parameters
include ventilation rates, temperature, blood pressure, heart rate,
respiratory rate, and other vital signs. Some parameters may
require separate monitoring devices (not illustrated) attached to
the patient, and the display on the device makes the information
immediately available to the person performing the CPR. Feedback
information includes pressure or force applied to the patient,
depth of compression, compression rate (i.e., cycles per minute),
duty cycle (i.e., portion of each cycle in which the patient is
compressed), and the like. Such feedback information can be
provided as discrete values, e.g., with gauges or digital readouts,
or may be provided with a light or sound system which indicates
when certain threshold values have been met or exceeded. It may be
further desirable to provide a pacing signal, e.g., either a sound
or flashing light, to facilitate maintaining a desired compression
rate.
FIG. 11 illustrates an embodiment of the invention wherein the
device has associated therewith one or more measuring and/or
display elements. Device 1100 comprises handle or element 1101 and
flexible contact pad 1102, and is similar in structure to device
700 shown in FIGS. 7-9, except that contact pad 1102 of device 1100
may optionally include one or more measuring and/or display
elements. For example, in addition to adhering to a patient's chest
as previously described, contact pad 1102 may serve as a platform
for measuring a variety of physiological parameters, e.g.
electrocardiogram parameters; provide a means to apply electricity
to the body, e.g. accomplish defibrillation; provide a means to
apply drugs to the body; provide a surface for installing a liquid
crystal display (LCD) screen to display various feedback
information; provide a means to house various body sensors, e.g.
bioimpedance sensors; and provide reference features to aid in the
proper placement of the device on the patient's chest.
Referring now to FIG. 11, contact pad 1102 may include imbedded
automated external defibrillator (AED) electrodes 1103 and 1104
connected to AED leads 1105 and 1106, respectively. Electrodes 1103
and 1104 extend to the lower surface of contact pad 1102 and may be
coated with the same adhesive material that covers the lower
surface 1112 to facilitate electrocardiographic monitoring (ECM)
and/or electrical defibrillation. Leads 1105 and 1106 include wires
or other electrical conductors for connecting electrodes 1103 and
1104 to external ECM and/or electrical defibrillation equipment in
a conventional manner. Contact pad 1102 may also optionally include
electronic LCD display 1107, which shows average compression forces
applied over a certain number of cycles, and electronic LCD display
1108, which shows average decompression forces over the same number
of cycles. In addition, contact pad 1102 may optionally include a
blinking light-emitting diode (LED) metronome to aid in the timing
of the compression and expansion strokes. In some embodiments, such
displays or signaling mechanisms may be positioned on or coupled
with handle 1101. Furthermore, contact pad 1102 may include
reference notch 1110 on its forward edge (closest to the patient's
head) to aid in properly locating the patient's sternum and a
reference notch 1111 on its rearward edge (closest to the patient's
feet) to aid in properly locating the xyphoid process. References
notches 1110 and 1111 may be used to properly place device 1100 on
the patient's chest so as to prevent injury to the patient during
compression and expansion strokes.
The device of the present invention may also be employed in a
powered or automated system, for example, such as the automated
reciprocating system 1200 as illustrated in FIG. 12. Surface
element 1201 may be adhered to body surface 1208 in the manner
previously described. Compression element or handle 1202 may be
secured to a vertical drive element 1203, which is attached to a
reciprocating lever arm 1204. Lever arm 1204 may be driven in a
wide variety of ways. As illustrated, a fixed fulcrum point 1205 is
provided by post 1206 and lever arm 1204 is reciprocated up and
down by a piston and cylinder 1207 to provide the desired
compression and expansion of chest 1208.
According to embodiments disclosed herein, devices and methods for
actively compressing and expanding an area of the human body may
include a compression element configured to pressed and lifted, and
a flexible surface element operably coupled with the compression
element and configured to be removably attached to a body part over
a contact area. The compressive element can be adapted to apply a
compressive force to the body part through the surface element over
a compressive area when the compression element is pressed. The
contact area can be sized to be at least twice as large as the
compressive area. Certain embodiments of the present invention are
useful in the performance of cardiopulmonary resuscitation and
advanced cardiac life support procedures. By alternately pressing
and lifting the surface element with the compression element, the
patient's chest can be compressed and expanded to improve induced
ventilation and circulation. In an exemplary device, a dome-shaped
handle is attached to the upper surface of a flexible contact pad
by a short connecting stem structure. The bottom end of the
connecting stem defines the compressive area and the lower surface
of the contact pad secured to a patient's chest defines the contact
area. In other embodiments, various elements may be associated with
the contact pad to, for example, measure a physiological parameter,
display patient feedback information, apply electricity, apply a
drug, provide a sensor, provide a reference to aid in the proper
placement of the surface element on the body part, etc. For
automatic applications, a mechanical drive member may be secured to
the compression element.
In some instances, a treatment device may include means to record
the compression events, to store the data, to simultaneously or
contemporaneously transmit or analyze data related to the treatment
to the operator, or to transmit or analyze data related to the
treatment to the operator following a patient arrest, to assess the
quality of cardiopulmonary resuscitation administered by the
operator, and to provide feedback to the operator regarding the
quality of the administered cardiopulmonary resuscitation either
during or after the arrest. Relatedly, an exemplary treatment
device for actively compressing and expanding an area of the body
can include a compression element that is configured to be pressed
and lifted, a flexible surface element operably coupled with the
compression element and configured to be removably attached to a
body part, an interface for displaying information to and receiving
information from an operator, a processor coupled with the
interface, and a memory coupled with the processor. The memory can
be configured to store a plurality of code modules for execution by
the processor. The plurality of code modules can include a module
for recording a compression event history, a module for storing the
compression event history, a module for assessing a cardiopulmonary
resuscitation quality factor, and a module for providing feedback
to the operator based on the cardiopulmonary resuscitation quality
factor.
Embodiments of the present invention encompass systems and methods
for instructing the operator or user to perform a certain number of
compressions prior to initiating active compression and
decompression (pulling up on the chest). For example, systems and
methods may involve instructing the operator to perform 30
compressions before they begin active compression and
decompression. Such techniques can help to ensure that the pad
appropriately adheres to the chest. In some cases, the device
software can guide the user to perform a number of (e.g. 30)
compressions before the display starts guiding the user to perform
compressions and decompressions. Relatedly, a device for actively
compressing and expanding an area of the body may include a
compression element that is configured to be pressed and lifted, a
flexible surface element operably coupled with the compression
element and configured to be removably attached to a body part, an
interface for displaying instructions to an operator, a processor
coupled with the interface, and a memory coupled with the
processor. The memory can be configured to store a plurality of
code modules for execution by the processor. The plurality of code
modules can include a module for providing operator instructions to
perform a number of compressions prior to initiating active
compression and decompression.
Further, methods and systems described herein can incorporate or be
used in conjunction with techniques that involve providing a volume
exchange cardiopulmonary resuscitation treatment to a patient that
encompasses compressing the patient's chest during a compression
phase and lifting upward the patient's anterior chest wall and
occluding the patient's airway during a decompression phase.
Optionally, the step of occluding the patient's airway can include
occluding the airway with a one-way valve. In some cases, the step
of occluding the patient's airway includes occluding the airway
with a valve system that allows an operator to ventilate the
patient. Techniques may also include ventilating the patient with
the valve system. In some cases, it is possible to ventilate the
patient by provide a positive pressure ventilation through or
around the one-way valve. Optionally, techniques can include
actively removing respiratory gases from the patient's lungs with a
low-level vacuum. In some cases, the low-level vacuum can be
continuous. In some cases, the low-level vacuum can be
intermittent. These treatment approaches can also include actively
withdrawing respiratory gases from the patient's lungs, and
subsequently delivering a positive pressure breath to the patient.
In some cases, the positive pressure breath can be delivered with a
period of positive end-expiratory pressure, either before or after
the positive pressure ventilation. These treatment method and
device approaches can also include aspects of positive end
expiratory pressure, positive pressure ventilation, or both, such
as those described in U.S. Patent Application No. 61/218,763 filed
Jun. 19, 2009 and U.S. patent application Ser. No. 12/819,959 filed
Jun. 21, 2010 the contents of which are incorporated herein by
reference for all purposes.
Relatedly, active compression decompression cardiopulmonary
resuscitation treatments described herein can be performed in
conjunction with the use of systems and methods for occluding the
patient's airway, modulating airway pressure, or providing
impedance-threshold therapy to a patient. Exemplary
impedance-threshold techniques include those described in U.S. Pat.
Nos. 5,551,420, 5,692,498, 6,062,219, 6,526,973, 6,604,523, 7,210
,480, 6,986,349, 7,204,251, 7,195,012, 7,185,649, 7,082,945,
7,195,013, 7,836,881, and 7,766,011, the contents of which are
incorporated herein by reference for all purposes. For example, an
impedance threshold device can be connected to a patient,
optionally via a facemask, and active compression decompression CPR
can be performed on the patient. The impedance threshold device can
lower intrathoracic pressure during the decompression phase by
impeding passive inspiratory gas exchange during the recoil phase,
while also allowing periodic positive pressure ventilation. The
impedance threshold device can be configured to provide an
inspiratory resistance of 16 cm H.sub.2O and less than 5 cm
H.sub.2O expiratory impedance, for example.
In some cases, active compression decompression cardiopulmonary
resuscitation treatments described herein can be performed in
conjunction with the use of systems and methods for providing,
facilitating, or modulating negative airway pressure, such as
impedance threshold device (ITD) techniques or intrathoracic
pressure regulator (ITPR) techniques. Exemplary ITPR approaches are
describe in previously incorporated U.S. patent application Ser.
No. 12/819,959 filed Jun. 21, 2010. ITD and ITPR techniques can be
used to enhance circulation, and may involve a valve system
interfaced to a person's airway. Both can be used to lower
intrathoracic pressure during the chest wall recoil phase of CPR,
thereby enhancing the transfer of blood from outside the thorax
into the right heart. Exemplary ITD systems can be configured to
prevent or inhibit respiratory gas flow to the person's lungs
during the decompression phase until a negative airway pressure
achieved equals the opening pressure of the valve system. Exemplary
ITPR systems can include a valve system that is used to withdraw
air from the lungs via an active vacuum source until a negative
airway pressure is achieved. According to some embodiments, ITD
approaches can provide perfusion on demand by regulating pressures
in the thorax during states of hypotension. ITD techniques may
utilize the interdependence of the body's respiratory and
circulatory systems to create a vacuum (negative pressure) within
the chest during the recoil phase of CPR, which follows each chest
compression. ITD techniques can regulate the influx of respiratory
gases into the chest during the chest wall recoil (relaxation or
decompression) phase, which lowers the intrathoracic pressure and
draws more venous blood back to the heart. Improved blood return to
the heart (preload) results in improved blood flow out of the heart
(cardiac output) during the subsequent compression. Thus, despite
its placement into the ventilation circuit, an ITD device can
operate as a circulatory enhancer device that works during chest
compressions, for example during the chest wall recoil phase of
CPR. Whereas ITD techniques can be based on vacuum associated with
recoil, ITPR techniques can involve the active application of a
vacuum. Exemplary ITPR techniques can be used to generate
controlled negative endotracheal pressure (ETP). In some cases, an
ITPR system may include a pressure regulator that combines a
continuous vacuum source, a regulator valve system, a means to
provide intermittent PPV, and an inspiratory ITD, such as that
described by Yannopoulos et al. in "Intrathoracic Pressure
Regulation Improves 24-Hour Survival in a Porcine Model of
Hypovolemic Shock" Anesth. Analg., Vol. 104 No. 1:157-162 (January
2007). Exemplary ITPR techniques are also described by Yannopoulos
et al. in "Intrathoracic pressure regulation improves vital organ
perfusion pressures in normovolemic and hypovolemic pigs"
Resuscitation 70(3):445-53 (September 2006). The entire content of
both of these journal articles is incorporated herein by reference
for all purposes. In some cases, an ITPR system may include an ITD
mechanism that, rather than operating to decrease intrathoracic
pressure, instead functions as a safety valve to prevent the vacuum
from going extremely negative, and can optionally be replaced by
another type of safety valve. Thus, in some instances, in an ITPR
technique the negative pressure can be generated by a vacuum line,
and not by a ITD mechanism.
Systems and methods for applying guided active compression
decompression cardiopulmonary resuscitation as described herein are
well suited for use in conjunction with abdominal counter-pulsation
and/or compression of the lower extremities, and other treatment
techniques such as those described in U.S. patent application Ser.
No. 12/165,366 filed Jun. 30, 2008 (Lower Extremity Compression
Devices, Systems And Methods To Enhance Circulation, for enhancing
venous return. The entire content of this application is
incorporated herein by reference for all purposes. For example,
guided active compression decompression cardiopulmonary
resuscitation can be used in combination with techniques or devices
that compress the lower extremities using counter pulsation, gas
inflated cuffs, fitted around a portion of the thighs or the entire
lower body, which can be triggered by the decompression phase of
CPR. The lower extremity device accomplishes two main objectives.
Such combination treatments are well suited for use in increasing
circulation during cardiac arrest and CPR and other states of low
blood pressure.
Exemplary Chest Compression Treatments and Systems
Performing CPR may include performing standard CPR or performing
active compression decompression (ACD) CPR. The method may also
include binding, manually or with an abdominal compression device,
at least a portion of the person's abdomen. It may also include
techniques to prevent blood flow to the legs, for example by
binding the lower extremities, either continuous or in a
synchronized manner with chest compressions. The method may also
include at least temporarily preventing or impeding airflow to the
person's lungs during at least a portion of the relaxation or
decompression phase using an impedance threshold device (ITD) that
is coupled with the person's airway. Such ITDs may entirely or
substantially prevent or hinder respiratory gases from entering the
lungs during some or all of the relaxation or decompression phase
of CPR. As one specific example, an ITD may prevent respiratory
gases from entering the lungs during the decompression phase until
the person's negative intrathoracic pressure reaches a certain
threshold, at which point a valve opens to permit respiratory gases
to enter the lungs. The method may also include regulating the
airflow to or from the person's lungs using an intrathoracic
pressure regulator (ITPR). Such ITPRs may actively extract gases
from the lungs during some or all of the relaxation or
decompression phase of CPR. For example, a vacuum source may
provide a continuous low-level vacuum except when a positive
pressure breath is given by a ventilation source, e.g. manual or
mechanical resuscitator. The applied vacuum decreases the
intrathoracic pressure. Improving the artificial circulation
created by the CPR may include increasing the carotid blood flow or
increasing systolic and diastolic blood pressures. The method may
also include stopping CPR and then restarting it multiple times,
such as by, for example, in 30 second epochs for four cycles, to
help preserve heart and brain function from reperfusion injury.
Such a process may be referred to as stutter CPR. If stutter CPR
(either ACD CPR or standard CPR) is to be performed manually,
instructions and/or an aid may be provided so that the rescue
personnel will have information about the sequence of delivering
CPR and SNP, including in some embodiments, how to deliver the drug
or drugs and perform stop/start or stutter CPR. In some cases,
devices used to perform CPR may be programmed to perform stop/start
or stutter CPR or have such a mode available.
In a further embodiment, blood flow within a patient who is in
cardiac arrest is modulated or controlled to control blood flow to
the heart and brain, with or without the administration of a
vasodilator drug. This is done so that the vital organs receive
blood in a controlled fashion. This may be particularly useful as
changes in blood flow may facilitate release of endogenous
vasodilators. In one aspect, blood flow is controlled or modulated
so that the vital organs slowly receive additional blood over time.
This may be done in a ramping fashion where the amount of blood
supplied to the vital organs is slowly increased over time, or in a
"stutter" fashion where blood is circulated to the vital organs for
a certain time, then stopped, then again circulated. In some cases,
combinations of the two methods could be used. In one specific
aspect, blood circulation is controlled by stopping and starting
CPR to protect against reperfusion injury by post-conditioning.
Another feature encompassed by embodiments of the present invention
is the ability to control or modulate blood flow within a patient
who is in cardiac arrest, and in particular, to control blood flow
to the heart and brain, with or without the administration of a
vasodilator drug, such that the vital organs receive blood in a
controlled fashion. This may be particularly useful as changes in
blood flow may facilitate release of endogenous vasodilators. More
specifically, blood flow is controlled or modulated so that the
vital organs slowly receive additional blood over time. This may be
done in a ramping fashion where the amount of blood supplied to the
vital organs is slowly increased over time, or in a "stutter"
fashion where blood is circulated to the vital organs for a certain
time, then stopped, then again circulated. In some cases,
combinations of the two methods could be used.
Merely by way of example, blood circulation may be ramped up over
time so that initially the blood flow to the vital organs may be
about 5% to 100% of what a healthy person may expect to receive
with normal heart function. Over a time period of about <1
minute to over an hour, the circulation may be increased so that
the blood flow to the vital organs is about 5% to about 100% and
even higher of what a healthy person may expect to receive. The
ramping function could be linear, non-linear, or may jump in
discrete steps.
For the "stutter" process, blood may be circulated to the vital
organs for set start and stop times, such as by causing circulation
for about 40 seconds, and then stopping circulation for about 20
seconds, and then resuming circulation for 40 about seconds, and
then stopping circulation for about 20 seconds, etc. The time
intervals where circulation occurs and is stopped could remain the
same, or could vary over time. For example, the time during which
circulation occurs could increase over time. The time during which
circulation is stopped could also vary over time, such as by
decreasing the length of the stopping periods over time.
Blood circulation may be facilitated in a variety of ways,
including manual or automated CPR or ACD CPR, external or internal
blood pumps, pressure cuffs, lateral gravity (g) acceleration, and
the like. Software programs may be employed to control circulation
devices so that blood circulation to the vital organs may be
controlled as just described. Similarly, manual instructions may be
provided to rescuers performing manual blood circulation
techniques, such as standard CPR. Further, instructions may be
provided for when to administer a vasodilator drug during the
process, if appropriate.
As one specific example, the effectiveness of CPR with SNP or a
SNP-like drug can be further enhanced by providing CPR for a period
of time, for example 40 seconds, and then stopping for 20 seconds,
and then resuming CPR for 40 seconds, and then stopping CPR for 20
seconds, and then resuming CPR. Use of between 0.05 and 1 mg of
epinephrine during this post-conditioning process can be used to
further improve circulation of blood flow to the heart and brain
and long-term neurologically-intact survival rates. If such a
"stutter" CPR process (either ACD CPR or standard CPR) is to be
performed manually, a kit may be provided with instructions and/or
a mechanical aid so that the rescue personnel will have information
about the sequence of delivering CPR and SNP, including in some
embodiments, how to deliver the drug or drugs and perform
stop/start or stutter CPR. In some cases, CPR will be performed
using a mechanized device, and such devices used to perform CPR may
be programmed to perform stop/start or stutter CPR or have such a
mode available.
One specific example of such a method is based on the observation
that mechanical post conditioning (PC) with intermittent initiation
of flow ("stutter" reperfusion) has been shown to decrease
infarction size in ST elevation infarction and decrease ischemic
stroke size in animals. An experiment was performed to determine
whether when using sodium nitroprusside-enhanced (SNPeCPR)
cardiopulmonary resuscitation (CPR), mechanical post conditioning
with stutter CPR (20-second CPR pauses), begun immediately on
SNPeCPR initiation, improves 24-hour cerebral function compared to
12 hours of therapeutic hypothermia (TH) post resuscitation.
This was shown in an experiment using 14 anesthetized and intubated
pigs that underwent 15 minutes of untreated VF followed by 5
minutes of SNPeCPR comprised of active compression decompression
CPR plus an inspiratory impedance threshold device combined with
abdominal binding. The ITD prevented respiratory gases from
entering the lungs during the decompression phase of CPR. In this
example, the ITD had a safety check valve that would allow for
inspiration when the intrathoracic pressure was less than minus 16
cm H2O, which does not occur during CPR. The abdomen in this
example was compressed with 40-50 lbs of pressure, applied
continuously with a bend human arm, using the forearm and a force
gauge. Further, 2 mg of sodium nitroprusside (SNP) were given IV at
minute 1 and 1 mg at minute 3 of CPR. All animals received in
addition 0.5 mg of epinephrine at minute 5, 30 seconds before the
first defibrillation attempt. Six animals (PC group), were treated
with 40 seconds of SNPeCPR and the first dose of SNP were followed
by 20-second pauses (cessation of perfusion) and 20 second of
SNPeCPR for at total of 4 cycles for up to 3 minutes. After that
animals had uninterrupted SNPeCPR until defibrillation at minute 5.
The other 8 animals (TH group) had SNPeCPR for a total of 5 minutes
without interruptions. The TH group received 12 hours of TH (core
temp=33.degree. C.). The PC group received no TH. Cerebral
performance was scored at 24 hours by a veterinarian blinded to the
treatment group.
During SNPeCPR, there were no hemodynamic differences except for a
significantly higher aortic pressure response to epinephrine at min
5 (SBP/DBP; 148.+-.12/78.+-.7 in the PC group versus
110.+-.9/62.+-.5 mmHg in the TH group, p<0.05). Return of
spontaneous circulation rates and 24-hour survival was 100% for
both groups. CPC was significantly lower in the PC group (1.+-.0)
versus the TH group (2.4.+-.0.8), p<0.01. Hence, in this porcine
model of cardiac arrest and SNPeCPR, mechanical PC with pauses in
compressions at the initiation of the resuscitation efforts
prevented 24-hour neurological dysfunction after 15 minutes of
untreated VF and was superior to TH.
FIG. 13 illustrates aspects of a treatment method according to
embodiments of the present invention. As shown here, method 1300
includes performing a first conditioning protocol for increasing
circulation in the individual, as indicated by step 1310,
performing a second conditioning protocol for pausing or reducing
circulation in the individual following the first conditioning
protocol, as indicated by step 1320, and performing a third
conditioning protocol for increasing circulation in the individual
following the second protocol, as indicated by step 1330. In some
instances, the conditioning protocols can be performed by an
operator based on instructions 1305 for administering a chest
compression treatment. As shown here, treatment instructions 1305
may include audio instructions, visual instructions, or any
combination thereof, for performing repeated chest compressions on
the individual. According to some embodiments, methods may include
providing such instructions to the operator. Instructions may be
provided to the operator, for example, by any of the treatment
systems described herein, for example systems such as those
depicted in FIG. 1A or FIG. 4. In some cases, instructions may be
provided, at least in part, by an auxiliary device that is separate
from a cardiopulmonary resuscitation system. For example,
instructions may be provided to an operator by a mobile phone or
any other electronic device. In some cases, some or all of the
instructions may be stored by the system. In some cases, some or
all of the instructions may be received by the system and
transmitted to the operator by the system. Hence, any or all of the
treatment protocols can be performed by the operator based on the
instructions. In some instances, the first conditioning protocol
includes compressing the chest in a repeated manner for a certain
number of chest compressions. In some instances, the second
conditioning protocol includes ceasing chest compressions. In some
instances, the third protocol includes again compressing the chest
in a repeated manner.
According to some embodiments, the first conditioning protocol may
include a series of periodic active chest compressions and
decompressions. In some cases, the third conditioning protocol may
include a series of periodic active chest compressions and
decompressions. In some cases, each of the first and third
conditioning protocols comprise a series of periodic active chest
compressions and decompressions. Optionally, treatment methods may
include administering an electrical defibrillation treatment to the
individual. Relatedly, treatment instructions provided by the
system may include operator instructions for delivering an
electrical defibrillation treatment to the individual. In some
cases, treatment methods may include modulating a pressure within
an airway of the individual. Relatedly, treatment instructions
provided by the system may include operator instructions for
modulating a pressure within an airway of the individual. It is
understood that treatment instructions described herein may
encompass instructions for a single operator, as well as
instructions for multiple operators, for example in situations
where more than one operator may be involved with administering a
treatment to an individual.
FIG. 14 illustrates aspects of a treatment system according to
embodiments of the present invention. As shown here, system can be
configured to provide guidance to an operator, for example for
administering a circulatory treatment to an individual. Hence,
system may be configured to provide such instructions in any way
that can be understood or perceived by an operator. For example,
system may provide at least a portion of the instructions in an
audio format. For example, the system may include a loudspeaker
that transmits instructions by sound for performing treatment
steps, which can be heard by an operator. Such auditory
instructions may include voice commands such as "Begin Chest
Compressions", "Cease Chest Compressions", "Resume Chest
Compressions", and the like. Similarly, system 400 may provide at
least a portion of the instructions in a visual format. For
example, the system may include a graphical user interface that
transmits instructions which can be visualized by an operator. Such
visual instructions may include text or display messages such as
"Begin Chest Compressions", "Cease Chest Compressions", "Resume
Chest Compressions", and the like. In some case, visual
instructions can be provided by lighted icons. For example, a green
light can provide a signal that the operator should begin chest or
compressions, and a red light can provide a signal that the
operator should cease chest compressions. According to some
embodiments, instructions for administering treatment protocols may
be provided as a combination of visual and audio signals. For
example, the system may emit a sound command of "Begin Chest
Compressions" and at the same time display a text or visual display
instructing the operator to begin chest compressions. Similarly,
the system may emit a sound command of "Cease Chest Compressions"
and at the same time display a text or visual display instructing
the operator to cease chest compressions. In some cases, system can
include one or more features or components of the various systems
described herein, such as those depicted in FIG. 1A or FIG. 4.
The system or device may also include a button or input mechanism
as a means by which a rescuer may select one of at least two CPR
options. In option A, bystander CPR has been performed previously
by lay rescue personnel, and no stutter CPR as described herein are
to be delivered, and thus the device is configured or programmed to
provide no instructions for the stutter method of CPR. The device
would be programmed, once the button A is pushed to instruct on how
to perform CPR without intentional interruptions. If there was no
lay rescuer CPR or bystander CPR previously performed, then a
selection of Option B would configure the device to provide the
rescuer instructions on how to perform stutter CPR with the
intentional interruptions and optionally provide feedback when it
was not being performed adequately or as proscribed so the rescuer
could improve what they are doing and perform the appropriate
CPR.
As shown in FIG. 14, in some cases system may include a module 1402
that stores, generates, or receives treatment information. In some
cases, system may include a module or operator interface 1404 that
transmits, provides, or displays instructions, optionally based on
the treatment information. A set of instructions 1410 may include
instructions for performing a first conditioning protocol 1420 for
increasing circulation in the individual, instructions for
performing a second conditioning protocol 1440 for pausing or
reducing circulation in the individual following the first
conditioning protocol, and instructions for performing a third
conditioning protocol 1460 for increasing circulation in the
individual following the second protocol. The first conditioning
protocol may include compressing the chest in a repeated manner for
a certain number of chest compressions. Hence, as illustrated here,
in response to or based on the instructions, the operator can
compress the chest in a repeated manner for a certain number of
chest compressions as indicated by step 1430. The second protocol
may include ceasing chest compressions. Hence, as illustrated here,
in response to or based on the instructions, the operator can cease
chest compressions, as indicated by step 1450. The third protocol
may include again compressing the chest in a repeated manner.
Hence, as illustrated here, in response to or based on the
instructions, the operator can again compress the chest of the
individual in a repeated manner, as indicated by step 1470.
According to some embodiments, each of the first and third
conditioning protocols include a series of periodic active chest
compressions and decompressions. In some cases, each of the first
and third conditioning protocol include a duration, and the first
conditioning protocol duration is different from the second
conditioning protocol duration. In some cases, each of the first
and third conditioning protocol include a duration, and the first
conditioning protocol duration is equal to the second conditioning
protocol duration. In some instances, the instructions may include
guidance to the operator to repeat certain aspects of the
treatment. For example, as shown by the arrow 1480 between the
third and second protocol instructions, the treatment instructions
may guide the operator to cease chest compressions following the
compression protocol of step 1470.
Related embodiments of the present invention encompass systems for
applying guided active compression decompression cardiopulmonary
resuscitation to an individual by an operator. For example, as
illustrated in FIG. 15, an exemplary system 1500 may include a
compression element 1510 that is pressed and lifted by an operator,
a flexible surface element 1520 coupled with the compression
element 1510 and removably attachable to a chest area of the
individual, and an operator interface 1530 that provides guidance
to the operator as to how to perform chest compressions. System
1500 may also include a processor 1540 operably coupled with the
operator interface 1530, and a memory 1550 that is configured to
store instructions executable by the processor 1540 to provide a
set of operator instructions to perform various conditioning
protocols. For example, the memory 1550 may store instructions
executable by the processor 1540 to provide a set of instructions
to the operator to perform a first conditioning protocol for
increasing circulation in the individual by compressing the chest
in a repeated manner for a certain number of chest compressions.
Further, the memory 1550 may store instructions executable by the
processor 1540 to provide a set of instructions to the operator to
perform a second conditioning protocol for pausing or reducing
circulation in the individual following the first conditioning
protocol by stopping chest compressions for a certain time
duration. Moreover, the memory 1550 may store instructions
executable by the processor 1540 to provide a set of instructions
to the operator to perform a third conditioning protocol for
increasing circulation in the individual following the second
protocol by again compressing the chest in a repeated manner for a
certain number of chest compressions. In some cases, each of the
first and third conditioning protocols include a series of periodic
active chest compressions and decompressions. In some cases, each
of the first and third conditioning protocol comprise a duration,
and the first conditioning protocol duration is different from the
second conditioning protocol duration. In some cases, each of the
first and third conditioning protocol include a duration, and the
first conditioning protocol duration is equal to the second
conditioning protocol duration. In one example, the first
conditioning protocol includes a duration of about 40 seconds, the
duration of the second conditioning protocol is about 20 seconds,
and the third conditioning protocol includes a duration of about 40
seconds. As shown in FIG. 15, system 1500 can include a display
subsystem 1560 that provides at least a portion of the guided
treatment instructions. System 1500 may also include an audio
output device 1570, such as a loudspeaker, that provides at least a
portion of the guided treatment instructions. According to some
embodiments, an operator interface 1530 may include a display
subsystem 1560, an audio output device 1570, or both, that provide
at least a portion of the guided treatment instructions. In some
instances, the system may also include a means 1580 for delivering
an electrical defibrillation treatment to the individual. In some
embodiments, the set of operator instructions can be based at least
in part on a physiological parameter of the patient. For example, a
patient parameter may include a ventilation rate, a body
temperature, a heart rate, a respiratory rate, a vital sign, an end
tidal carbon dioxide measure, or the like. In some embodiments, a
system 1500 may include a pressure regulator mechanism 1590 that
modulates pressure within an airway of the individual. According to
some embodiments, memory 1550 may be configured to store
instructions executable by the processor 1540 to receive
information indicating whether the operator is following the set of
operator instructions, and to provide a signal indicating whether
the operator is following the set of operator instructions. As
shown here, system or device 1500 may include an input mechanism or
button 1501 that can be actuated by an operator or user, to provide
an input information to the processor regarding whether a patient
or subject has previously received CPR, which can configure the
system to provide (or not provide) instructions for stutter CPR, as
described elsewhere herein.
In some embodiments, systems or devices can be configured to
provide a set of operator instructions to perform a first
conditioning protocol for increasing circulation in the individual
by compressing the chest in a repeated manner for a certain time
duration, a second conditioning protocol for pausing or reducing
circulation in the individual following the first conditioning
protocol by stopping chest compressions for a certain time
duration, and a third conditioning protocol for increasing
circulation in the individual following the second protocol by
again compressing the chest in a repeated manner for a certain time
duration. For example, the first time duration may be about 40
seconds (e.g. administration of CPR), the second time duration may
be about 20 seconds (e.g. cessation of CPR), and the third time
duration may be about 20 seconds (e.g. administration of CPR). In
an exemplary embodiment, the set of instructions may subsequently
guide the user or operator to cease CPR for about 20 seconds,
administer CPR for about 20 seconds, cease CPR for about 20
seconds, and administer CPR for about 60 seconds. Following the CPR
application instructions, the device or system may optionally
instruct an operator or individual to administer to treated subject
a vasopressor drug such as adrenalin and/or a vasodilator such as
sodium nitroprusside. Where such therapeutic agents are
administered to the patient or subject being treated, the device or
system may instruct an operator or individual to subsequently
provide further CPR for an additional period of time, ranging from
between 0 seconds and 60 seconds, for example, and may also
instruct an operator or individual to administer an electrical
shock to the subject being treated. The system or device may also
assess one or more physiological parameters of the subject being
treated, or cue the user or operator to assess one or more
physiological parameters of the subject being treated, including
end tidal CO.sub.2 levels, ECG waveforms, and the like, as a way to
determine when to deliver the electrical shock. Hence, the timing
of the delivered electrical shock can be based on one or more
assessed physiological parameters of the subject.
In some instances, methods may involve delivering CPR with a device
that delivers standard CPR and/or ACD CPR. In some instances, CPR
can be delivered in conjunction with an ITD and/or ITPR therapy. In
some instances, the CPR optionally in combination with ITD and/or
ITPR can be provided to the subject in an automated manner. In some
instances, the CPR optionally in combination with ITD and/or ITPR
can be provided to the subject manually. Hence, embodiments of the
present invention may incorporate combined ACD CPR and negative
intrathoracic pressure treatment modalities, including aspects of
combined treatments such as those described in Aufderheide et al.,
"Standard cardiopulmonary resuscitation versus active
compression-decompression cardiopulmonary resuscitation with
augmentation of negative intrathoracic pressure for out-of-hospital
cardiac arrest: A randomised trial." Lancet 377:301-311 (2011), the
content of which is incorporated herein by reference.
In some instances, techniques disclosed herein may involve,
following a period of untreated ventricular fibrillation,
performing CPR with a number of defined and controlled pauses
during the first three minutes of basic life support (BLS) in
conjunction with a means to optimize blood flow to the heart and
brain subsequently, so as to normalize brain and heart function
soon after arrest. In some instances, the guided administration of
three to four twenty-second pauses within the first three minutes
of CPR provides a therapeutic effect to the subject. Such
combinations of simple and specific mechanical interventions can
protect the heart and brain from injury and subsequently enhance
CPR-generated blood flow to the heart and brain leading to improve
resuscitation outcomes, optionally in the absence of epinephrine or
other vasopressors.
Intermittent pauses during initiation of CPR is thus helpful for
treating subjects in cardiac arrest. Controlled stutter CPR after
prolonged global ischemia in cardiac arrest exhibits benefits for
the myocardium and mitigates post resuscitation cardiac dysfunction
that contributes heavily to post resuscitation morbidity and
mortality. ACD CPR with stutter CPR, optionally in combination with
ITD and/or ITPR can be widely applied at the first responder level,
without ALS support. The concurrent use of controlled pauses during
the initiation of ACD CPR (optionally with ITD and/or ITPR) can
limit reperfusion and subsequent ischemic injury. Systems and
devices as disclosed herein can be configured to guide a rescuer
such as a basic EMS user or lay person on how to perform high
quality CPR with controlled pauses and simultaneously monitor and
record that performance. These techniques can improve clinical
outcomes and provide a means to help assure, assess, and maintain
performance of quality CPR. Without being bound by any particular
theory, it is thought that the type of intentional pauses described
herein may operate to harness endogenous protective processes
associated with specific mitochondrial protective mechanics.
Surprisingly, the techniques described herein indicate that the
brain may demonstrate the potential for full recovery after 15
minutes of global ischemia with no flow following the
administration of a non-invasive treatment.
ACD CPR utilized a suction cup or other attachment mechanism to
actively lift the chest wall during the decompression phase
enhances the refilling of the heart in between compressions, and
can be combined with either an ITD or another means to lower
intrathoracic pressures and prevent the influx of respiratory gases
into the lungs during the chest decompression phase of CPR. An ITD
may operate by allowing air to exit the chest during each
compression but impedes air entry during the chest recoil or
decompression phase until airway pressure falls below -10 or -16 cm
H.sub.2O, depending upon the ITD used. Due to the rapid
transmission of intrathoracic vascular pressures and intrathoracic
pressure throughout the chest and brain, use of ACD CPR+ITD
decreases right atrial pressure and ICP while increasing aortic
pressure and forward flow, thereby providing enhanced blood flow to
the heart and brain. As disclosed herein, ACD CPR devices can
utilize software to instruct the user how to perform ACD CPR, and
can also utilize an adhesive pad which adheres to the patient's
chest to provide ACD CPR. The device can be configured to provide
audible and visual cues which instruct a user to perform ACD CPR,
optionally in conjunction with controlled intermittent CPR, and
also optionally in conjunction with ITD and/or ITPR therapy.
Exemplary systems or methods may also include an input mechanism
that receives information from a user or rescuer related to whether
the patient has previously received CPR treatment. For example, a
device such as ACD CPR device 100a of FIG. 1 may include a button
or toggle on the front of the device, which may be activated or
pressed by a rescuer. Relatedly, input mechanism 1501 of FIG. 15
may provide such an input. The input may allow the rescuer to
select one of at least two CPR options. The selection may be based
on whether the subject has received CPR treatment (e.g. manual CPR
administered by a bystander), before the rescuer begins using the
ACD CPR device. For example, Option A may be selected if the
subject has previously received CPR treatment from a bystander. In
this case, upon selection of Option A, the device is configured to
provide instructions to the operator which do not include the
administration of a stutter CPR. Alternatively, Option B may be
selected if the subject has not previously received CPR treatment.
In this case, upon selection of Option B, the device is configured
to provide instructions to the operator which do include the
administration of stutter CPR.
Exemplary systems or devices can be configured to provide a user or
operator with audible and/or visual prompts for administering one
or more aspects of the treatment methods disclosed herein. For
example, systems or devices may include an interface that guides
the user to perform CPR with controlled pauses, and that provides
the user with continuous feedback on the quality of the CPR
administered. Systems or devices may also incorporate software that
allows the user to download or transmit information on the quality
of the CPR. In some instances, systems or devices are configured to
instruct a user to provide 20 second pauses during CPR. In some
instances, systems or devices are configured to provide guidance
and real-time feedback to the user to improve the effectiveness of
CPR. The systems and devices disclosed herein encompass manual ACD
CPR apparatuses capable of providing instructions for performing
combined ACD CPR and controlled pause CPR therapy, optionally in
conjunction with ITD and/or ITPR, as well as real-time feedback on
the quality of CPR being performed. Exemplary systems or devices
may include a visual interface that cues the user to stop (PAUSE)
or start (RESUME) compressions during the initial four minutes (or
other initial duration time period) of CPR.
FIG. 16 depicts an exemplary interface configuration according to
embodiments of the present invention. As shown here, system 1600
may have an interface 1610 that includes a display 1620 for
numerically showing the target compression rate, as well as the
actual rate (e.g. number of chest compressions per minute).
Interface 1610 may also include a display for showing warnings 1630
(e.g. "slow down"). The warnings may be provided to the operator
visually and/or audibly. Further, the interface may provide a
signal or indication to the operator regarding the
compression/decompression depth/force, and can also provide a
signal 1640 indicating that target depths and/or forces have been
exceeded. In some instances, the interface 1610 may provide a
breath indicator 1650, which provides a visual cue to an operator
or rescuer to administer a breath to the patient or subject being
treated. Interface 1610 may also include an animated direction
indicator 1660, which guides the user to push on the device toward
the patient (e.g. downward facing arrow), or to pull on the device
away from the patient (e.g. upward facing arrow). The interface
1610 may further include scrolling dots or indicia 1670 along the
upper and/or lower bounds of the depth and/or force targets, thus
providing a target for cadence as well as compression and/or
decompression.
Exemplary devices may include a force sensor that provides
feedback, which can be used to instruct the user to achieve an
appropriate compression target. In some instances, a device may
include an accelerometer that provides feedback, which can be used
to provide the user with specific depth information. For example, a
printed circuit board mounted micro-machined single axis capacitive
accelerometer, utilizing a double integration of the output of the
accelerometer may be sufficient to calculate the relative position.
Alternatively, 2 or 3 axis sensors may be employed to generate
comprehensive position assessments. Combined accelerometer and
force sensor devices can provide accurate compression/decompression
readings, particularly in situations (e.g. CPR is performed on a
soft surface such as a mattress) where accelerometers alone may not
provide an accurate assessment. Systems or devices may employ
algorithms or computing means that compare values from the
accelerometer and force sensor to determine whether adequate force
is being applied in order to achieve a desired amount of
displacement (e.g 2 inches). If a target or desired displacement is
not achieved, the device can provide a visual and/or audible
warning that additional force is required to achieve meaningful
chest compressions. Although many of the indicators or cues
discussed herein are described in terms of audio or visual terms,
it is also understood that systems and devices can be configured to
provide feedback, cues, guidance, indicators, and the like in
tactile terms. For example, the device may be configured to vibrate
so as to provide a particular cue (e.g. deliver compressions with
more force) to the user. Hence, any of a variety of visual, audio,
and/or tactile means, optionally in any combination thereof, may be
employed by the system or device to provide instructions or
feedback to the user or operator.
Stutter CPR techniques are described in Segal et al. "Ischemic
postconditioning at the initiation of cardiopulmonary resuscitation
facilitates functional cardiac and cerebral recovery after
prolonged untreated ventricular fibrillation" Resuscitation, Apr.
18 2012 [Epub ahead of print] and Yannopoulos "Controlled pauses at
the initiation of sodium nitroprusside-enhanced cardiopulmonary
resuscitation facilitate neurological and cardiac recovery after 15
mins of untreated ventricular fibrillation" Crit Care Med. May
40(5):1562-9 (2012), the contents of which are incorporated herein
by reference. Stutter CPR techniques are also described in U.S.
patent application Ser. No. 13/554,458 filed Jul. 20, 2012.
Accordingly, the systems and devices disclosed in the instant
application can be configured to perform any aspect of the stutter
CPR techniques disclosed in those references, and can also be
configured to instruct a rescuer or operator to perform any aspect
of such stutter CPR techniques.
Embodiments of the invention have now been described in detail for
the purposes of clarity and understanding. However, it will be
appreciated that certain changes and modifications may be practiced
within the scope of the appended claims.
* * * * *
References